Lead Validation Engineer
3 weeks ago
Key Responsibilities:
In this role, you will report directly to the Validation Manager and will be instrumental in supporting various projects. Your responsibilities will include:
- Implementing a risk-based methodology for the validation of systems, ensuring adherence to Annex 11, 15, and industry standards such as GAMP 5.
- Developing validation strategies, assisting system owners with impact and risk assessments, and determining validation needs for equipment, facilities, and systems.
- Creating and executing validation protocols for equipment, facilities, utilities, computerized systems, and processes.
- Overseeing the requalification processes for systems and equipment.
- Supervising validation tests conducted by external vendors.
The ideal candidate will possess:
- A degree or equivalent qualification in a scientific discipline.
- Proven experience in leading validation efforts within the biopharmaceutical Advanced Therapy Medicinal Products (ATMP) sector or similar environments.
- In-depth knowledge of relevant regulations including GMP, ICH, FDA, USP, and EP.
- Demonstrable expertise in the creation and execution of validation lifecycle documentation such as URS, DQ, IQ, OQ, and PQ.
- A solid understanding of aseptic processing and cleanroom technologies.
Applicants must have the legal right to work in the UK. Please ensure to reference the job title in all communications.
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