Senior Equipment Validation Engineer – Pharma GMP

Life Science Recruitment; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Life Science Recruitment seeks a Senior Equipment Engineer for an onsite 12-month contract in Dublin. You will drive expert validation support across the full lifecycle, coordinating qualification activities for Vial and Syringe filling, formulation, inspection and clean utility areas in line with GMPs.

The role requires 6+ years in validation/commissioning management, a relevant engineering or science degree, and experience with sterile/biotech equipment in pharma.

Qualifications

• 6+ years experience in science, engineering or validation, commissioning and qualification management.
• Technical qualification at third level or equivalent in Engineering or science.
• Extensive experience managing commissioning and qualification for Pharmaceutical/Biotech projects.
• Experience with sterile/biotech equipment within pharmaceutical industry is preferred.

Responsibilities

• Provide expert technical validation support across the full lifecycle from design to validation maintenance (e.g., periodic review).
• Coordinate qualification activities and keep equipment and utility systems in a validated state.
• Develop or qualify approaches and equipment family strategies.
• Assist in URS and QRAES development for equipment and automated systems.
• Develop and approve C&Q/Validation Plans, FAT, SAT, IV/FTs, QRAES, IOQs, PQs for Vial, Syringe filling, formulation, inspection and clean utility areas in line with GMPs and regulatory standards.
• Assist in assessment of project change controls ensuring Validation standards and requirements are met.
• Liaise with Engineering, Commissioning, PD, external vendors to ensure quality by design principles are followed.
• Improve equipment validation lifecycle process and ensure ongoing compliance with regulations.
• Participate in regulatory inspections, filings and RTQs.
• Update and maintain SOPs in accordance with site and corporate requirements.
• Take ownership for quality compliance in all activities you are responsible for.
• Ensure site change control procedures are adhered to.

Skills

Validation lifecycle

GMP compliance

Risk-based approach

Technical validation

Education

Engineering or science degree

Job description

Life Science Recruitment seeks a Senior Equipment Engineer for an onsite 12-month contract in Dublin. You will drive expert validation support across the full lifecycle, coordinating qualification activities for Vial and Syringe filling, formulation, inspection and clean utility areas in line with GMPs.

The role requires 6+ years in validation/commissioning management, a relevant engineering or science degree, and experience with sterile/biotech equipment in pharma.