
Commissioning and Validation Expert
2 weeks ago
We are seeking highly skilled individuals to fill key roles in commissioning, qualification, and validation within the pharmaceutical industry.
Key Responsibilities:
- Develop comprehensive documentation for commissioning, qualification, and validation processes, including protocol development, execution, and report generation at client sites.
- Support documentation for pharmaceutical facilities, equipment, and utilities.
- Write and execute protocols for field verification.
- Prepare detailed summary reports.
Essential Qualifications:
- Bachelor's or Master's degree in a relevant science or engineering discipline.
- 2-7 years' experience in commissioning and qualification within an FDA-regulated environment.
- Strong expertise in facilities startup, troubleshooting, building automation, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQ, etc.
- Leadership in cGMP compliance and CQV services.
- Excellent problem-solving skills and attention to detail.
- Ability to work independently and as part of a team.
- Experience with life science manufacturing processes (biotech, aseptic processing, gene therapy, etc.).
- Familiarity with Baseline Guide 5 (Second Edition) is advantageous.
What We Offer:
A dynamic work environment that fosters growth and collaboration. Opportunities for professional development and advancement. A competitive compensation package that reflects your value to the organization.
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