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Validation Specialist
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Location | Hertfordshire |
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Job Type | Permanent |
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Salary | £NEG |
Blackfield Associates are currently supporting an exciting biopharmaceutical manufacturing organisation, to recruit for a Validation Specialist to join the organisation initially on an 18-month FTC basis.
Responsibilities
The role is to support the qualification and validation of manufacturing systems designed for the production of high-quality drug products, supporting clinical trials and future commercial programs. This role is based in Hertfordshire, with some travel to other London sites.
Key Responsibilities
- Perform qualification and validation of manufacturing equipment, analytical test equipment, facilities, services, computerised systems, and processes.
- Author validation lifecycle documents, including risk assessments, GAMP assessments, and various qualification stages (Design, Installation, Operational, Performance).
- Collaborate with cross-functional teams to deliver tasks efficiently and on schedule.
- Conduct validation testing with third-party vendors and suppliers.
- Maintain the validation master plan, including requalification and periodic reviews.
- Participate in and support internal and regulatory quality inspections.
- Assist with additional tasks to ensure compliance within validated systems.
Requirements
Required Experience & Qualifications
- Essential:
- Biotechnology, pharmaceutical, or medical device industry experience.
- Experience in qualifying process equipment in biopharmaceutical or related industries.
- Strong understanding of cGMP and pharmaceutical quality systems (change control, deviation, CAPA).
- Strong verbal and written communication skills.
- Team-oriented and self-motivated.
- Preferred:
- BS or MS in Engineering or a science-based discipline.
- Knowledge of cell biology and immunology.
- Familiarity with regulatory guidance governing cell-based and biopharmaceutical development.
Apply
If this position interests you, and you would like to learn more or explore other available jobs that could also match your skill set, please apply today or email melissa@blackfieldassociates.com