CSV Lead

Fully Onsite - 12 month contract role.

We are partnering with a leading global life sciences company constructing a €330m greenfield biopharmaceutical facility in Kerry. This state-of-the-art, highly sustainable plant will focus on the aseptic fill-finish and lyophilization of advanced biologics (mAbs and ADCs) and is now seeking a Senior CSV Engineer contractor to join the team.

The Role:

• Own and drive the sitewide CSV strategy, lifecycle governance, and risk management frameworks for the greenfield facility.
• Oversee the complete validation lifecycle (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, Summary Reports) across sterile equipment and automated platforms.
• Lead and mentor a team of CSV engineers and contractors, managing resources to meet key project and commissioning milestones.
• Direct validation efforts for critical systems, focusing on aseptic processing, lyophilization, automated inspection, and fill-finish lines.
• Act as the CSV SME during regulatory audits (FDA, HPRA, EMA), ensuring full compliance with GAMP 5, ALCOA+ data integrity, and 21 CFR Part 11 / Annex 11.
• Collaborate with CQV, IT, Automation, and Operations leadership to align validation goals with site schedules and operational targets.

Requirements:

• Degree in Engineering, Computer Science, or a related Scientific discipline.
• 10+ years of CSV experience in a GMP biopharma environment, including 3+ years in a team lead or project lead role.
• Demonstrated track record on large-scale greenfield capital projects.
• Strong technical expertise in sterile fill-finish, lyophilization, and automated control systems (DeltaV, MES, SCADA).
• Deep understanding of GAMP 5, Data Integrity (ALCOA+), and international regulatory expectations (FDA, EMA, HPRA).