Laboratory Validation Engineer

Laboratory Validation Engineer

Location: Westport, Co. Mayo, Ireland

Join a global biopharmaceutical leader and make a meaningful impact on patient lives. A state-of-the-art facility in Westport is seeking a dedicated Laboratory Validation Engineer to lead the validation of laboratory equipment, systems, and processes that support life-saving therapies. This is a pivotal role within the Quality Control (QC) Pharma Department, offering long-term career growth and the chance to contribute to critical regulatory compliance initiatives.

Key Responsibilities

• Lead and coordinate the site validation master plan, including prospective, concurrent, and retrospective validation studies.
• Execute validation projects to ensure compliance with global regulatory standards (FDA, HPRA, and corporate policies).
• Act as the validation project lead, liaising with cross-functional teams and compiling all associated documentation to audit-ready standards.
• Participate in risk assessments and design reviews for various business units.
• Generate and track weekly validation metrics (including GTW QMS, EHS, and Compliance Wire reports).
• Support periodic review cycles, including PQRs, Laboratory Equipment Reviews, and Regulatory Reviews.
• Maintain expertise on evolving regulatory guidance to ensure site compliance.
• Contribute to internal and external audit activities, including preparation, participation, and response.
• Promote a strong EHS culture, supporting environmental management systems and continuous quality improvement.
• Actively engage in departmental meetings, APEX initiatives, and quality and safety programmes.

Qualifications & Experience

• Bachelor’s degree in a science-based or engineering discipline.
• Minimum of 3 years’ experience in the pharmaceutical or biopharmaceutical industry.
• Proven project management skills with the ability to lead cross-functional teams.
• Strong critical thinking, problem-solving, and documentation capabilities.
• Proficient in Microsoft Office tools (Excel, Word, PowerPoint).
• Effective communicator with excellent conflict resolution and stakeholder engagement skills.
• Subject matter expertise in one or more of the following areas: Equipment, Facilities, Aseptics, Process Validation, CPV, CSV, Cleaning Validation.

Why Choose Westport, Co. Mayo?

Experience the perfect balance of professional fulfilment and quality of life in Westport—an award-winning town known for its vibrant community, breathtaking coastal scenery, and affordable, family-friendly lifestyle in the heart of Ireland’s scenic west coast.