Validation Engineer

New Brunswick, NJ, US • Posted 60+ days ago • Updated 2 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Manufacturing
URS
Risk Assessment
Acceptance Testing
System Integration Testing
IQ
OQ
PQ
Lifecycle Management
Testing
Change Control
Regulatory Compliance
Quality Assurance
Auditing
Biology
Chemistry
Information Management
Information Technology
Computer Science
Pharmaceutics
Medical Devices
Good Manufacturing Practice
Software Development
Software Development Methodology
Computerized System Validation
GxP
Enterprise Resource Planning
MES
LIMS
Documentation
Management
Data Integrity
Cyber Security
Soft Skills
Communication
Leadership
Collaboration

Summary

Job Description:
Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Key responsibilities include developing and reviewing validation documentation (protocols, reports), performing risk and impact assessments, coordinating testing (UAT, SIT), managing change controls, and supporting audits to maintain the validated status of systems like ERP, MES, and LIMS.
Responsibilities:

Documentation & Planning: Author, review, and approve CSV lifecycle documents, including validation plans, user requirements specifications (URS), risk assessments, protocols, and reports.
Validation Execution: Coordinate and execute testing activities, such as User Acceptance Testing (UAT), System Integration Testing (SIT), and Installation, Operational, and Performance Qualifications (IQ, OQ, PQ).
Regulatory Compliance: Ensure all computer systems comply with cGMP, 21 CFR Part 11, Annex 11, and other global regulatory requirements.
System Lifecycle Management: Oversee the entire CSV lifecycle, from design and development to testing and ongoing maintenance of the validated status of systems.
Change Control: Manage change controls, deviations, and non-conformances related to CSV to ensure continuous compliance.
Cross-Functional Collaboration: Quality Assurance (QA), and automation teams, as well as stakeholders and vendors, to achieve project goals.
udits & Inspections: Support internal and external audits, including FDA inspections, by providing documentation and expertise on CSV activities.
Data Integrity: Perform data integrity assessments for computer and automation systems to ensure data is accurate and reliable.

Requirements:

bachelor's degree in a technical, scientific, or related field, such as Engineering, Biology, or Chemistry, is often required or preferred.
Master's degrees in related fields like Information Management, Information Technology, or Computer Science are sometimes preferred.
Experience: Significant experience (often 9+ years) in Computerized System Validation (CSV) within the pharmaceutical or medical device industry.
Knowledge: Thorough understanding of cGMP regulations, the software development lifecycle (SDLC), and CSV principles, especially 21 CFR Part.
Software/System Experience: Familiarity with common GxP systems like ERP, MES, LIMS, and specific automation platforms such as DeltaV.
Technical Skills: Strong documentation skills, experience with validation management software (e.g., Kneat), and an understanding of data integrity and cybersecurity principles.
Soft Skills: Excellent communication, strong leadership, and the ability to collaborate effectively in cross-functional, global teams.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 5e5911d6ca8cefad989a316ed0aea6b1
Posted 30+ days ago

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