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Qa validation engineer

Sligo
Sterling Engineering
Validation engineer
Posted: 2h ago
Offer description

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 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 Requirements 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 Key Competencies 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 Additional Information 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

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