CSV Lead

Morgan McKinley; Munster; Sur place; EUR 110 000 - 165 000; Plein temps

Résumé du poste

Morgan McKinley seeks a senior Computer System Validation Lead for a major greenfield biopharma project in Kerry, Ireland. You will own the CSV strategy, govern lifecycle processes, and mentor a team of CSV engineers and contractors to ensure timely validation across aseptic fill-finish lines.

You will serve as the CSV SME during FDA/EMA audits, ensuring compliance with GAMP 5, ALCOA+, and 21 CFR Part 11. Strong collaboration with CQV, IT, Automation, and Operations is essential.

Qualifications

• 8+ years CSV experience in GMP biopharma.
• 3+ years in team lead or project lead role.

Responsabilités

• Own and drive the CSV strategy, lifecycle governance, and risk management for the greenfield facility.
• Oversee validation lifecycle (IQ/OQ/PQ, URS, Risk Assessments, Summary Reports) across sterile equipment and automated platforms.
• Lead CSV engineers and contractors to meet project milestones.
• Direct validation efforts for aseptic processing, lyophilization, automated inspection, and fill-finish lines.
• Act as CSV SME during regulatory audits (FDA, HPRA, EMA) ensuring data integrity and 21 CFR Part 11/Annex 11 compliance.
• Collaborate with CQV, IT, Automation, and Operations leadership to align validation with schedules.

Connaissances

CSV leadership

GAMP 5

ALCOA+ data integrity

FDA/EMA/HPRA regulations

Regulatory audits

Formation

Engineering or related science degree

Outils

DeltaV

MES

SCADA

Description du poste

We are partnering with a leading global life sciences company constructing a €330m greenfield biopharmaceutical facility in Kerry. This state-of-the ar**t**, highly sustainable plant will focus on the aseptic fill-finish and lyophilization of advanced biologics (mAbs and ADCs) and is now seeking a Computer System Validation (CSV) Lead 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.
• 8+ 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).