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Pharmaceutical Technical Validator
2 weeks ago
We are seeking an experienced Commissioning, Qualification, and Validation expert with a strong background in the pharmaceutical and cGMP industry.
- Lead and participate in Engineering, Procurement, Construction, and Validation activities for GMP facilities.
- Develop, execute, and review IQ, OQ, PQ validation protocols for equipment, facilities, and utilities.
- Conduct root cause analysis and lead quality investigations (deviations, CAPA, change control).
- Manage validation schedules and resource alignment.
- Support manufacturing process setup and technical activities.
- Perform FAT/SAT activities and temperature mapping.
- Utilize Delta V, Kneat, Veeva, and Trackwise.
Key Requirements:
- 8+ years of CQV experience in pharma/cGMP.
- Strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, ASME BPE.
- Proven problem-solving and project coordination skills.
- Excellent communication abilities.
- Bachelor of Science in Chemical/Biological Engineering or related field.
- USP
- CAPA
- Construction
- Risk Assessment
- GMP
- Root Cause Analysis
- Procurement
- Python
- Change Control
- ASME
- Project Coordination
- Regulatory Requirements
- Manufacturing
- Commissioning
- Trackwise
- Mapping
