What are the responsibilities and job description for the Validation Manager position at Cybotic System?
Must be from Pharmaceutical Background
Validation Master Plan Development / Update – VMP, CVMP
Develop and write applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, VQs
Validation of: Autoclaves, Depyrogenation Tunnels, Stability / Incubator / Refrigeration Chambers, Cleaning Equipment / Processes, Analytical Instruments, Facilities, Media Fills, Smoke Studies, Kaye Instrumentation
Knowledge of cGMP requirements on validation methods and principals including FDA, ISPE, GAMP guidelines and FDA, CFR Part 11
BA or BS Degree in Engineering, Chemistry or Microbiology with preference for the Engineering Sciences from a four-year college or university or equivalent work experience in the pharmaceutical industry, minimum 5 years in a management role in Validation in pharmaceutical industry. Certified Engineer or CQE is a plus. Sterile injectable experience required.
Dear Partners,
We need a new set of candidates for this position. All the existing ones have been rejected in the interview due to the below reasons.
1. They were unable to speak about specific validation activities and did not provide in-depth knowledge.
2. All the answers were high-level.
3. Unsure of his ability for hands-on experience/knowledge.
Please note, that you are evaluating the candidate as per the below points while you are sourcing.
1. They should be from Pharmaceutical Background with extensive experience with Sterile Injectables.
2. The candidate should have at least 5 years of Management role in Validation.
3. They should have worked on Validation Master Plan Development
4. Validation experience should be hands-on; (Autoclaves, Depyrogenation Tunnels, Stability / Incubator / Refrigeration Chambers, Cleaning Equipment / Processes, Analytical Instruments, Facilities, Media Fills, Smoke Studies, Kaye Instrumentation)
