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.