Senior CAPEX Project Manager – Pharmaceutical Manufacturing
BioTalent · Cork
Job description
About the role
We are seeking a Senior CAPEX Project Manager to lead the end‑to‑end delivery of complex capital investment projects within regulated pharmaceutical manufacturing environments. You will be accountable for safe, on‑time, on‑budget delivery while ensuring compliance with GMP and corporate standards.
Key responsibilities
- Lead the full project lifecycle from feasibility and business case through design, construction, commissioning, qualification and handover.
- Manage medium to large‑scale pharmaceutical manufacturing and infrastructure projects, including cleanrooms, utilities and production facilities.
- Oversee external EPC/EPCM contractors, suppliers and partners to meet safety, quality, cost and schedule targets.
- Develop and maintain execution plans, budgets, schedules, governance frameworks and risk‑management strategies.
- Ensure continuous compliance with cGMP, GxP, EHS, validation and corporate engineering standards.
- Coordinate cross‑functional teams across Engineering, Validation, Quality, Operations, Procurement, Supply Chain and Finance.
- Drive project controls, cost forecasting, change control and risk mitigation.
- Lead stage‑gate reviews and provide reporting to senior leadership and investment governance.
- Support regulatory inspections, audits and strategic manufacturing network initiatives.
Required profile
- Bachelor’s degree in Engineering (Chemical, Mechanical, Process or related); advanced degree preferred.
- 15+ years of capital project delivery experience in pharmaceutical, biotechnology or regulated life‑science environments.
- Proven track record delivering large‑scale projects exceeding $25 M.
- Experience leading large, cross‑functional, international teams and managing EPC/EPCM contractors.
- PMP, PRINCE2 or equivalent certification preferred.
Required skills
- Project Management (PMP/PRINCE2 certified)
- GMP manufacturing knowledge
- Cleanroom and utilities design expertise
- Validation principles for pharmaceutical facilities
- Scheduling, budgeting, governance and risk management
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Published 7 hours ago
Expires 1 month from now
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BioTalent
Cork