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Validation Analyst

Job Description

Job Responsibilities:

· Create and maintain technical writing standards for the Automation and Engineering unit.

· Write and create automation periodic evaluation reports for automated systems used in commercial pharma manufacturing, analytical testing and training/document tracking/retention.

· Perform and document investigations and risk assessments of pharmaceutical complex related deviations and anomalies.

· Write and oversee specific validation review/approvals for modifications/change controls/revision histories to documents (standard specialized operating procedures, work instructions, job aids, etc,).

· Create and review documents designed to explain and test automated validation process control systems and laboratory automation.

· Author test plans/test cases/matrices/scripts/pharmaceutical evaluations and IOS~ documents to support validation activities.

· Author, edit, review and maintain system design documentation (such as User Requirement Specifications, Functional Specifications, Software Design Specification, etc.), following GAMP 5 guidance.

· Author, edit, review, evaluate and maintain department cGMP documentation: standard operating procedures, procedural quizzes, work instructions, standard specialized engineering specifications, job aids, FMEA, gap analysis, memos/addendums/amendments, on-the-job training documentation, instructor-led training material,  forms/templates/ manuals, equipment/system genealogy/ lineage documentation, etc.

 

Qualification:

This position requires a minimum of Bachelor Degree in Pharmaceutical, Drug Regulatory Affairs, Chemistry, or related field.


Job Tags

Validation Analyst, Validation, GAMP, FMEA, GMP, 
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 Job Type : Full Time
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Job Responsibilities:· Ensure compliance with internal and external GxP system policies and regulations · Implement or schedule validation testing and studying clinical product characteristics or requirements and conferring with management to determine validation objectives and standards · Perform validation of GxP and non-GxP systems and collaborate with teams in making critical decisions with respect to validation · Perform risk assessments in determining GxP applicability associated risk and resulting validation activities per... read more
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Job Responsibilities:• Ensure that the assigned validation activities are performed timely and in line with the current requirements and cGMP, handling any deviations associated with these activities.• Responsible and accountable for meeting defined timelines for delivery of Performance Qualification technical reports to complete process validation activities and executions for mixing, milling, downtime, and aseptic studies.• Develop validation protocols, strategies and author technical reports ( eg. Pre Validation studies, Performance Qua... read more
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 Job Type : Full Time
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Job Responsibilities:· Ensure compliance with internal and external GxP system policies and regulations· Implement or schedule validation testing and studying clinical product characteristics or requirements and conferring with management to determine validation objectives and standards· Perform validation of GxP and non-GxP systems and collaborate with teams in making critical decisions with respect to validation· Perform risk assessments in determining GxP applicability associated risk and resulting validation activities per risk.... read more
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 Job Type : Full Time
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Job Responsibilities: • Provide Computer System Validation (CSV) support/insight for deployment of JDE 9.1. And guidance on all aspects of documentation, testing, quality review etc. • Manage the investigation and deviation process to ensure focus on root cause determination and timely closure. • Write, review, revise, and approve CSV related deliverables (VP, VSR, FRA, HLRA, SRS, RTM, specifications, protocols, deviations, investigations, CAPA, etc.) • Manage the investigation and deviation process to ensure focus on root cause determination a... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/17/18 1:28 PM
Job Responsibilities:· Ensure compliance with internal and external GxP system policies and regulations. · Implement or schedule validation testing and studying clinical product characteristics or requirements and conferring with management to determine validation objectives and standards. · Perform validation of GxP and non-GxP systems and collaborate with teams in making critical decisions with respect to validation. · Perform risk assessments in determining GxP applicability associated risk and resulting validation activities ... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/24/19 9:27 AM
Job Responsibilities: · Create and maintain technical writing standards for the Automation and Engineering unit. · Write and create automation periodic evaluation reports for automated systems used in commercial pharma manufacturing, analytical testing and training/document tracking/retention. · Perform and document investigations and risk assessments of pharmaceutical complex related deviations and anomalies. · Write and oversee specific validation review/approvals for modifications/change controls/revision histories to d... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 01/20/20 3:49 PM
Job Duties:· Participate on computerized system validation and implementation project teams.  · Author computer system validation documentation ensuring compliance with applicable FDA Regulations that is 21CFRPart11 and 21CFRPart820. · Follow GAMP5 practices for authoring and reviewing Validation Documentation. · Implement formal testing of GxP computerized systems including identifying and implementing tools, setup of testing, documentation, approval and delivery. ... read more