Senior Validation Manager

14 hours ago

Dundalk, Louth, Ireland beBeeCompliance Full time €100,000 - €125,000
Job Description

We are seeking a highly skilled and experienced Associate Director to oversee the lifecycle of process equipment and validation at our site. This is a key role within our Engineering Leadership Team, responsible for ensuring activities meet regulatory requirements.

Responsibilities
  • Oversee the lifecycle of process equipment and validation from project initiation to commissioning, qualification, requalification, revalidation, and retirement.
  • Ensure technical and compliance governance for validated systems including process equipment, cleanrooms, utilities, laboratory systems, cleaning validation, thermal mapping, and computerised systems.
  • Lead design, specification, procurement, commissioning, qualification, and validation of GMP laboratory, utilities, computerised, manufacturing systems, and cleanroom environments for capital projects and new products.
  • Partner with Operations, Quality, and Project Management to deliver projects on time, within budget, and compliant with regulatory requirements.
  • Lead investigations into deviations, non-conformances, validation issues, and process equipment failures, implementing science-based, risk-focused CAPAs.
  • Maintain inspection readiness for process equipment and validation systems and act as SME for audits and regulatory inspections, ensuring documentation, systems, and practices are audit-ready.
Requirements
  • Proven experience establishing, developing, and scaling Process Engineering/Validation functions in greenfield or large-scale biotech environments.
  • Expertise in process equipment and validation lifecycle management within a c GMP-regulated biotech/biologics environment.
  • Knowledge of biotechnology manufacturing operations, large-scale unit operations, validation standards, and global regulatory requirements.
  • Proven ability to lead project delivery, validation strategy, and audit/inspection management.
  • Experience & Qualifications: Degree in Life Sciences, Chemical/Biological Engineering, or related discipline.
Skills and Qualifications
  • Process Equipment Design
  • Validation Lifecycle Management
  • c GMP Manufacturing
  • Bioprocess Engineering
  • ASME BPE
Benefits

• Bonus
• Life Assurance
• Pension
• VHI

Others

Support international sites and global engineering initiatives, including audits, as needed.

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