What are the responsibilities and job description for the CQV Engineer for GMP Compliance position at SciPro?
Job Description
The CQV Engineer will be responsible for leading commissioning, qualification, and validation activities for facilities, equipment, systems, and processes supporting the reliable production of personalized cell therapies.
This position requires a strong understanding of cGMP regulations, FDA/EU guidelines, and Good Tissue Practices (cGTP). The ideal candidate will have experience working with batch records, SOPs, CQV protocols, and technical documentation.
Required Skills and Qualifications:
- Bachelor's degree in Science, Engineering, or a related technical field.
- At least 2 years of relevant experience, preferably in an aseptic manufacturing or cell therapy environment.
- Expertise in CQV processes, process optimization, and regulatory compliance.
- Familiarity with TrackWise, Comet, CMMS, Veeva, Maximo, Kneat, Kay, and AVS/Validator is a plus.
