What are the responsibilities and job description for the Validation Specialist (CQV) position at Katalyst Healthcares & Life Sciences?
Job Description:
- We're seeking a CQV Validation Specialist to perform commissioning, qualification, and validation (CQV) of process equipment, utilities, and facilities for a regulated pharmaceutical manufacturing site.
- The ideal candidate will have hands-on experience with IQ/OQ/PQ, cleaning validation, and temperature mapping in GMP environments.
- Execute and author IQ/OQ/PQ protocols for equipment, utilities, and facilities per the Validation Master Plan (VMP).
- Perform temperature mapping for controlled areas, storage units, and process systems.
- Support cleaning validation develop MACO calculations, perform swab/rinse sampling, and review analytical results.
- Lead and review validation documentation including protocols, reports, and risk assessments.
- Collaborate with Engineering, QA, and Manufacturing during commissioning and qualification activities.
- Support change controls, deviations, and CAPA related to validated systems.
- Participate in validation reviews and contribute to continuous improvement of site validation practices.
- Bachelor's degree in engineering, Biotechnology, Life Sciences, or related field.
- 3 6 years of CQV experience within pharmaceutical or biotech manufacturing.
- Strong understanding of GMP, FDA guidelines.
- Hands-on experience in equipment and cleaning validation, including utilities such as WFI, clean steam, and HVAC.
- Proficiency in temperature mapping tools (e.g., Kaye Validator or equivalent) preferred.