Computer System Validation Engineer

Vacaville, CA, US • Posted 27 days ago • Updated 10 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Pharmaceutical Industry
Manufacturing Execution System
MES
Process Control
URS
IQ
OQ
PQ
Collaboration
Quality Assurance
Regulatory Compliance
Data Integrity
Auditing
Training
Change Control
Computerized System Validation
Pharmaceutics
GxP
Documentation

Summary

Job Summary:

s a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulatory requirements.

Roles & Responsibilities:

Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports.
Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity.
Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations.
Provide training to stakeholders on validation requirements and best practices.
Maintain validation lifecycle documentation and change control records

Education & Experience:

Experience with Computer System Validation (CSV) in a regulated pharmaceutical or biotech environment.
Strong knowledge of GxP, FDA 21 CFR Part 11, and EU Annex 11.
Proficiency in authoring and executing validation documentation.

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: a43b8f70286b3851e1b324a16ea491ce
Posted 27 days ago

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Computer System Validation Engineer

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Job Details

Skills

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