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
2022-06-11hai this is for testing
Software Developer
AT001
2022-06-09hai this is for testing