Position: Commissioning and Qualification Validation Engineer (CQV) - cGMP Location: Greater Boston Area Contract length: 12 - 16 months
My client is looking to acquire a CQV engineer who will be responsible for supporting all projects, writing and executing validation protocols, and other CQV related responsibilities. This position requires 4 years of validation experience minimum within commissioning and qualification.
- Installation and operation verification and performance testing of new and used equipment
- Develop of project execution plan
- Produce commissioning, qualification and validation plans
- Review process models and sizing calculations for equipment, control valves, deviations and CAPAS
- Collaborate with Quality professionals to ensure a compliant manufacturing environment
- Assessing vendor validation packages
- Develop protocols using a risk based approach, complete trace matrices, report progress and roadblocks to the project team
- Bachelors in Engineering or Science related technical field
- 4 years minimum experience in biotech or pharmaceutical based GMP/cGMP environment
- Knowledge of US FDA and EU EMEA regulations
- Lean/Six Sigma certification
- Familiarity with FDA, ICH (, ISO, EU, PDA, ISPE, ASME(BPE)
- In-depth knowledge of FDA regulation 21 CFR part 11, 210, 211
If you satisfy the requirements above, or may know someone who satisfies these needs, please forward your resume to the attention of Ahmed Hassan and team at Real Staffing, Boston.
Sthree US is acting as an Employment Business in relation to this vacancy.