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QA Validation Engineer
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Tommy McKeown
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Contract
QA Validation Engineer
Department: Quality
Reporting to: Validation Team Lead
Overview
We are seeking a QA Validation Engineer to support the site validation program, ensuring compliance with regulatory, quality, and cGMP standards within a biopharmaceutical manufacturing environment.
Key Responsibilities
Department: Quality
Reporting to: Validation Team Lead
Overview
We are seeking a QA Validation Engineer to support the site validation program, ensuring compliance with regulatory, quality, and cGMP standards within a biopharmaceutical manufacturing environment.
Key Responsibilities
- Support and execute validation activities for equipment, utilities, processes, and systems
- Develop and maintain:
- Validation Master Plan (VMP)
- Project validation plans and schedules
- Generate and execute:
- Validation protocols (IQ/OQ/PQ)
- Final reports and investigations
- Manage change control, deviations, and CAPA processes
- Review and approve validation and quality documentation
- Ensure all activities are completed in line with cGMP and regulatory requirements
- Support audits (internal and external)
- Contribute to continuous improvement initiatives across quality and manufacturing
- Maintain compliance across production areas and support cross-functional teams
- Degree in Engineering or a scientific discipline
- Minimum 3 years’ experience in validation within a regulated (biopharma/pharma) environment
- Strong knowledge of:
- cGMP
- Validation lifecycle (IQ/OQ/PQ)
- Regulatory standards (FDA / EU GMP / GAMP)
- Excellent communication, organisation, and problem-solving skills
- Ability to work independently and within cross-functional teams
- Strong attention to detail with a Right First Time mindset
- Ability to manage multiple priorities and meet deadlines
- Proactive approach to issue resolution and compliance
- High level of autonomy with responsibility for delivering validation activities
- Regular interaction with internal teams and external auditors
- Commitment to maintaining safety, quality, and compliance standards at all times
