What are the responsibilities and job description for the Lead CQV Engineer position at Darwin Recruitment?
Role Summary :
We are seeking an experienced Lead CQV (Commissioning, Qualification, and Validation) Engineer to oversee CQV activities for a cutting-edge cell therapy manufacturing project . This role will involve managing the CQV lifecycle for critical equipment, utilities, and systems while ensuring compliance with regulatory and GMP standards. The Lead CQV Engineer will work closely with cross-functional teams, including automation, process engineering, and quality, to deliver a state-of-the-art facility.
Key Responsibilities :
Project Leadership :
Lead and coordinate all CQV activities, including planning, execution, and documentation, across process equipment, utilities, and facilities.
- Develop and manage the CQV Master Plan to align with project timelines and objectives.
Commissioning and Qualification :
Author, review, and approve CQV protocols (FAT, SAT, IQ, OQ, PQ) for critical manufacturing equipment, utilities, and automated systems.
Collaboration :
Work closely with the Automation Engineer to ensure integration and validation of automated systems, including SCADA, MES, and BMS.
Regulatory and Compliance :
Ensure adherence to 21 CFR Part 11, EU Annex 11, ISPE guidelines, and GAMP 5 standards.
Risk Management and Documentation :
Conduct risk assessments (e.g., FMEA) and ensure data integrity compliance across all systems.
Qualifications :
7 years of CQV experience in GMP-regulated environments, preferably in biopharmaceutical or cell therapy manufacturing.
Expertise in CQV lifecycle management, including protocol development and execution.
Preferred :
Why Join Us?
How to Apply :
Submit your resume and cover letter to wesley.cann@darwinrecruitment.com.
Darwin Recruitment is acting as an Employment Business in relation to this vacancy.
