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Careers

Validation Analyst

AT0023
2023-02-13

·       Develop, review, and approve validation policies, procedures, plans and protocols for the implementation of GxP procedures for the infrastructure and computer systems

·       Analyze and test the 21 CFR Part 11 compliance tracking applications that are designed to track down the applications currently being used to comply with FDA regulations and GAMP

·       Establishment of key deliverables of computer and automated validation; User Requirement Specifications (URS), Functional Requirement Specifications (FRS), GxP Risk Assessment (RA), IQ/OQ/PQ Test Scripts, Requirement Traceability Matrix (RTM), Validation Summary Report (VSR)

·       Develop Validation and Test Plans, specifications, supplier assessment and compilation of the data and results into final reports

·       Implement formal testing of GxP computerized systems including identifying and implementing tools, setup of testing, documentation, approval, and delivery

·       Focus on problem identification and involved in processing of CAPA (Corrective Action and Preventive Action) reports to ensure compliance with established procedure

·       Review and approval of the change request documentation which will be created as part of the regular Operational and Support of the systems

·       Making sure that all the project teams follow SDLC SOP and create appropriate SDLC deliverables that will be approved and stored in LEADs (document management system)

 

 

Qualification:

 

A bachelor’s degree in Pharmaceutical Science or a closely related field or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned subjects.  

Oracle EBS Consultant

AT0020
2023-02-13

·       Production support on R12 General Ledger, Accounts Payables, Financial Accounting Hub, Cash Management, Fixed Assets, iProcurement, Purchasing, AME workflows etc.

·       Assist the business in month-end closing process such as reports for consolidation, trial balances, period closing, GL closing, reporting currency ledgers, etc.

·       Work on iProcurement implementation for other functional areas.

·       Configure Invoice Workflow approval process for PO matched and non-PO invoices.

·       Assist business users in issues with data flow into Oracle EBS from source systems such as Ensura, ServiceBench, Wennsoft and UltiPro through FTP process.

·       Solve various Oracle issues reported by business users through Remedy Console ticketing tool

·       Work on Oracle SRs and RFCs as an Oracle On Demand customer through Oracle. Managed Cloud Services incorporating the changes required.

·       Create, maintain and update user documents and SOPs (user manuals, quick reference guides) to help business users accomplish their tasks.

·       Analyze business requirements for enhancements and customizations, design and develop a process.

·       Involve in system administrator activities such as user setups, defining responsibilities, value sets, Flexfields, data groups, request groups, lookups, registering applications, reports etc.

·       Knowledge of SQL developer and SQL queries & procedures to understand and analyze the issues and generate ad-hoc data extracts.

·       Integrate legacy systems into Oracle EBS for acquired companies.

·       Work on various set ups and creations of test data in system and configurations in modules like GL, AP, CE, FA and Purchasing.

·       Involve in requirements gathering, analysis, development, QA and post-production support and warranty.


Qualification:


This position requires a minimum of a Bachelor's Degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a Bachelor's Degree in one of the aforementioned subjects.  

 


Data Engineer

AT0019
2023-02-07

        Gathering requirements to understand requests and needs to provide the best solution possible.

        Executing design, development & deployment of ETL applications, preparing High Level Design & Low-Level Design Documents Developing interfaces, packages, and load plans.

        Leading team to handle complex business rules while balancing the fulfillment of stringent performance requirements.

        Performed end-to-end delivery of Pyspark, Spark SQL, Azure Data Warehouse (ADW), CI/CD and Production Support.

        Wrote scripts in Hive SQL for creating complex tables with high performance metrics like partitioning, clustering and skewing.

        Worked with google data catalog and other google cloud APIs for monitoring, query and billing related analysis for Big Query usage.

        Designing and developing code, scripts and data pipelines that leverage structured and unstructured data integrated from multiple sources.

        Implementing Data warehouse solution consisting of ETLs, on-premises to Cloud Migration and building and deploying batch and streaming data pipelines on cloud environments.

        Investigate Data Quality issues and generate presentable narratives based on biases possible due to incompleteness of data.

   Monitoring project progress & outstanding issues and ensuring the quality of the deliverables by onducting daily defect review meetings & extending post-implementation support to team members by defining standard practices.

 

Qualification:

 

This position requires a minimum of a bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Validation Engineer

AT0018
2022-12-27

·       Assist in updating the implementation lifecycle documents (i.e., Business Process Documents, Configuration Design Specification, Technical and Functional Design Specification).

·       Create /Review software validation plans, Qualifications test protocols, traceability matrices, reports and all software deliverables within the scope of validation.

·       Assisting with the verification, validation and debugging of software applications.

·       Participates in root cause analysis for problem solving. 

·       Support release management activities by reviewing and ensuring the pre-requisites are release prior to the release.

·       Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans.

·       Perform risk assessment document using risk assessment and identify the gaps and risk factors and risk mitigation plans of the system preparing of function and configuration.

·       Coordinate with cross-functional team for post approval of qualification protocols and validation summary report.

·       Assist in documenting the Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.

 

Qualification:

This position requires a minimum of a bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses

Software Developer

AT0017
2022-09-22

·        Responsible for continuous improvement of DevOps tools, processes, and procedures, as well as the deployment and troubleshooting of complex cloud solutions.

·        Build, maintain, and scale infrastructure for application environments.

·        Work with a variety of platforms including SCM Continuous Integration and Continuous Development along with Build and Release Management. Administration and deploying development CI/CD tools such as Git/Bitbucket, Jira, GitLab, Jenkins, Puppet, Bamboo, Confluence, Spunk, ELK, Nagios, Grafana, Servicenow, Teams, ControlM, Airflow, CloudWatch, Solarwind, etc.

·        Implement AWS services VPC, EC2, S3, RDS, IAM, Elastic load balancing, Auto scaling, Cloud Front, Elastic Beanstalk, Cloud Watch focusing on high-availability, fault tolerance, auto scaling in AWS Cloud.

·        Manage Ansible Playbooks with Ansible roles. Use file module in Ansible playbook to copy and remove files on remote systems. Create inventory in Ansible for automating the continuous deployment and written playbooks using YAML scripting.

·        Built Docker images using related base image that encapsulates different application versions which is deployed on AWS by configuring task and Services. Used Launch configuration and Lifecycle hooks to automate auto scaling by defining the metrics.

·        Deploy application which is containerized using Docker onto a Kubernetes cluster which is managed by Amazon Elastic Container Service for Kubernetes (EKS).

·        Setting up monitoring and alerting for Kubernetes cluster using open-source monitoring tools like Grafana, Prometheus.

·        Install Jenkins on Linux environment and integrated different tools like Maven, GIT, SonarQube, and Nexus with Jenkins and implemented master - slave configurations to run multiple build operations.

·        Own production incidents/issues and provide application support during and – on occasion –outside of normal business hours, responding to infrastructure incidents and alerts and escalating to other subject matter experts as necessary.

 

Qualification:

This position requires a minimum of  bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Java Developer

AT0016
2022-03-22


·        Analyzing the user requirements set on the Kanban board and gathering the requirement to get the issue resolved.

·        Debugging the code by adding breakpoints on Eclipse IDE, looking for the Splunk logs, checking SP Tool, and fetching records from BETA if issues noticed.

·        Implementing well-defined and efficient Java, JavaScript, and AngularJS code as per the requirement in the Kanban board.

·        Ensuring that the code design follows the preset guidelines.

·        Coding JUnit tests for the corresponding Java code for that month’s release.

·        Performing regression tests to check the software’s functionality with the rest of the components and ensuring the system is working as expected.

·        Testing the correct endpoints are being hit on the backend through Postman.

·        Developing Confluence pages providing an overview of the system, code, and testing, for future reference.

·        Participating in Software Development Life Cycle stages.

 

Qualification:

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Java Developer

AT0015
2022-01-20


·       Work within the rules team in conjunction with technology teams and business partners to design and develop business rules using Redhat Process Automation Manager and Java.

·       Design and develop various business processes and required work item handlers using drools, Java.

·       Understand and provide resolution for various business problems by architecting best technical solution in Redhat PAM.

·       Participate in designing and development of lean business process flow for redhat PAM along with technical teams.

·       SME support/Consultation for migration activities.

·       Design and implement end to end testing of rules using postman and automating the test cases using Cucumber.

·       Help development teams to solve day to day implementation issues.

·       Synchronize multiple teams to solve day to day implementation issues.

 

Qualification:

 

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Qlik Developer

AT0014
2022-08-22

·        Provide Knowledge Transfer of Current Business Processes for creating daily reports as directed by the Department.

·        Assess and determine best data workflows as directed by the Department.

·        Configure Qlik Data Connections to Source System(s) daily as directed by the Department.

·        Access and prepare Data Tables for Analytic-Ready Data Model as directed by the Department.

·        Create Qlik Scripting as directed by the Department.

·        Provide and create Qlik Data Modeling as directed by the Department.

·        Create and test Qlik application and dashboard design as directed by the Department.

·        Create Qlik Wireframing as directed by the Department.

·        Provide visualization development as directed by the Department.

·        Configure behavior of visualizations and dashboard as directed by the Department.

·        Provide layout testing as directed by the Department.

·        Develop customization and aesthetics for Qlik as directed by the Department.

·        Apply security modeling as directed by the Department.

·        Create   and provide testing for application/dashboard functionality as directed by the Department.

·        Provide Application Migration from Dev to Production Environment.

·        Create scheduling reload tasks to refresh data and Automate Process for Qlik application as directed by the Department.

·        Configure integration with Qlik N Printing for Scheduled Distribution as directed by the Department.

·        Design Reports –PDF, Microsoft Office, HTML, etc. as directed by the Department.

·        Deploy application on scheduled basis to as directed by the Department.

·        Provide training and handoff of new Qlik Dashboard as directed by the Department.

Qualification:

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Equipment QC Eng

AT0013
2022-08-10

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT0012
2022-08-09

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT0011
2022-08-08

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT0010
2022-08-05

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT009
2022-08-04

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT008
2022-08-03

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT007
2022-08-02

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT006
2022-08-01

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT005
2022-07-29

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT004
2022-07-28

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT003
2022-07-27

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Senior Software developer

AT002
2022-06-11

hai this is for testing

Software Developer

AT001
2022-06-09

hai this is for testing