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:
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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.
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Commissioning and Qualification:
- Author, review, and approve CQV protocols (FAT, SAT, IQ, OQ, PQ) for critical manufacturing equipment, utilities, and automated systems.
- Oversee the execution of protocols, ensuring compliance with GMP and regulatory requirements.
- Perform critical system verification, including utility startup, equipment qualification, and process validation support.
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Collaboration:
- Work closely with the Automation Engineer to ensure integration and validation of automated systems, including SCADA, MES, and BMS.
- Partner with process engineering, QA, and other stakeholders to ensure systems meet operational and compliance requirements.
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Regulatory and Compliance:
- Ensure adherence to 21 CFR Part 11, EU Annex 11, ISPE guidelines, and GAMP 5 standards.
- Support audits and inspections as the CQV Subject Matter Expert (SME).
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Risk Management and Documentation:
- Conduct risk assessments (e.g., FMEA) and ensure data integrity compliance across all systems.
- Maintain accurate and audit-ready documentation for all CQV activities.
Qualifications:
- Education: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
- Experience:
- 7+ years of CQV experience in GMP-regulated environments, preferably in biopharmaceutical or cell therapy manufacturing.
- Strong background in the qualification of process equipment, utilities (e.g., WFI, HVAC, compressed air), and automation systems.
- Skills:
- Expertise in CQV lifecycle management, including protocol development and execution.
- Proficiency in regulatory compliance frameworks (21 CFR Part 11, GAMP 5, ISPE).
- Strong leadership, communication, and organizational skills.
Preferred:
- Prior experience leading CQV efforts in cell or gene therapy projects.
- Familiarity with automation systems (SCADA, MES) and process control validation.
- Knowledge of continuous improvement practices in CQV and GMP compliance.
Why Join Us?
- Lead a critical project shaping the future of cell therapy manufacturing.
- Work with a dynamic, multidisciplinary team of industry experts.
- Competitive salary, benefits, and career growth opportunities in an innovative field.
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.
Wesley Cann