Do you have strong Validation experience? Have you got IPQ, CQV and PPQ experience? Within a Biotechnology, Pharmaceutical or Medical Device industry?

We are currently seeking a Validation Engineer to join a leading global Biopharma company in Westport, County Mayo, Ireland. The successful candidate will contribute to the growth of their multi-million-euro site and work within a diverse validation manufacturing team. Responsibilities include qualifying, validating, and revalidating all CGMP equipment, systems, and processes to meet global standards and regulatory requirements set by the FDA, HPRA, and other relevant authorities.

Key Responsibilities:

• Ensure compliance with validation requirements for new processes, equipment, or modifications to existing ones.
• Conduct IPQ (installation, performance, and qualification), CQV (Commissioning, Qualification, and Validation), and PPQ (Process Performance Qualification).
• Facilitate the PQR and regulatory review processes, as well as the Laboratory Equipment Review Process.
• Coordinate and manage validation projects.
• Maintain adherence to regulations and standards.
• Participate in departmental meetings and support Environmental Health and Safety (EHS) initiatives.
• Engage in audit processes and implement the site validation master plan.
• Qualifications/Experience Required:

Qualifications/Experience Required:

• Significant validation experience.
• Proficiency in IPQ, CQV, and PPQ methodologies.
• Prior experience in pharmaceutical manufacturing/production is essential.
• Steam sterilization experience.
• Bachelor's degree (Level 8) in Engineering Sciences.