Senior Project Manager – Capital Projects (Pharma)
Blackfield Associates · Cork
Description du poste
About the role
We are seeking a Senior Project Manager to lead client‑side capital investments for pharmaceutical manufacturing facilities. You will act as the primary liaison for GE Healthcare Capital (GEHC) projects, ensuring delivery that meets safety, GMP, quality, cost, and schedule standards.
Key responsibilities
- Represent the client side for CMO‑executed capital investments, overseeing EPCMV partners and ensuring compliance with GEHC safety, GMP, quality, cost, and schedule standards.
- Lead the full project lifecycle from concept, feasibility, and business case development through detailed design, construction, commissioning, qualification, and handover to operations.
- Manage medium‑ and large‑scale capital projects within GMP‑regulated pharmaceutical manufacturing environments.
- Develop and maintain robust execution plans, schedules, cost forecasts, risk registers, and governance structures.
- Ensure continuous compliance with cGMP, GxP, EHS, Lean, and corporate engineering standards throughout execution.
- Coordinate multi‑disciplinary teams including engineering, quality, validation, operations, procurement, and external EPCMV partners.
- Oversee contractor and supplier selection, contract negotiation, performance management, and change control.
- Drive rigorous cost control, risk mitigation, and stage‑gate reviews to meet investment objectives and cash‑flow requirements.
- Interface with regulatory and quality organizations to support inspections, audits, and regulatory submissions.
- Provide concise, decision‑focused reporting to senior leadership and investment governance forums.
Required profile
- Bachelor’s degree in Process, Chemical or Mechanical Engineering (Master’s preferred).
- 15+ years delivering medium to large capital projects in the pharmaceutical, biotechnology or regulated life‑sciences sector.
- Proven track record of managing projects exceeding $25 M in value.
- Extensive experience with small‑ and large‑molecule API manufacturing environments.
- Demonstrated leadership of large, cross‑functional, multicultural project teams.
- Professional project‑management certification (PMP, PRINCE2 or equivalent) strongly preferred.
Required skills
- cGMP and GxP compliance knowledge.
- Cleanroom design and pharmaceutical utilities expertise.
- Validation principles for regulated manufacturing.
- EPCMV contractor and complex supply‑chain management.
- Advanced cost control, scheduling, risk management, and governance.
- Project Management Professional (PMP) or PRINCE2 certification.
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Blackfield Associates
Cork