What are the responsibilities and job description for the CSV Engineer position at United Consulting Hub?
We are seeking a CSV Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotech environment.
Key Requirements:
- Hands-on experience with Computer System Validation (CSV)
- Strong understanding of GAMP 5 and 21 CFR Part 11
- Experience supporting QC laboratory systems and/or manufacturing equipment validation
- Ability to develop and review validation lifecycle documents (URS, IQ, OQ, PQ, Risk Assessments, Validation Reports)
- Experience working cross-functionally with QA, Manufacturing, Engineering, and IT teams
- Strong documentation and communication skills
Key Responsibilities
- :Develop, execute, and maintain CSV documentation and validation protocols for QC and manufacturing systems
- .Perform risk assessments and ensure compliance with GAMP 5, 21 CFR Part 11, and GMP requirements
- .Review and support validation lifecycle activities, including URS, IQ, OQ, PQ, and validation reports while collaborating with QA, Manufacturing, and IT teams