Lead CSV Engineer - Biopharma Greenfield Facility

Morgan McKinley; Munster; On-site; EUR 110,000 - 165,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

CSV leadership

GAMP 5

ALCOA+ data integrity

FDA/EMA/HPRA regulations

Regulatory audits

Education

Engineering or related science degree

Tools

DeltaV

MES

SCADA

Job description

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.