Our client, a biopharmaceutical company located in East Cork, is seeking a Senior Project Manager. The successful candidate will be responsible for the end-to-end delivery of large-scale pharmaceutical capital investment projects. The role operates within a regulated GMP environment and is responsible for leading cross-functional teams to deliver complex manufacturing, cleanroom, utilities, and infrastructure projects safely, on schedule, within budget, and in full regulatory compliance.
Responsibilities
Act as our client’s representative for CMO executed capital investments leading EPCMV partners and ensuring delivery to 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 pharmaceutical GMP manufacturing environments.
Develop and maintain robust project execution plans, schedules, cost forecasts, risk registers, and governance structures.
Ensure compliance with cGMP, GxP, EHS, Lean and corporate engineering standards throughout project execution.
Lead and coordinate multi-disciplinary project teams including engineering, quality, validation, operations, procurement, and external EPCMV partners.
Lead contractor and supplier management including selection, contract negotiation, performance management, and change control.
Drive rigorous cost control, from estimation to management, change management, and risk mitigation to meet approved investment objectives and operational cash flow requirements.
Drive stage gate reviews of projects in planning and execution phases to ensure strategy, timelines, sequences, resources are optimised for successful project delivery.
Interface with regulatory and quality organizations to support inspections, audits, and regulatory submissions as required.
Ensure safe execution of works through strong EHS leadership and application of best-in-class safety practices.
Provide concise, decision-focused reporting to senior leadership and investment governance forums, clearly articulating risks, trade-offs, and mitigation strategies.
Support long-range capital planning and strategic manufacturing footprint initiatives.
International travel is likely in this role potentially including weekends and multi-week stays. Travel of approximately up to 20 - 30% away from home.
Qualifications & Experience
Bachelor’s degree in Engineering (Process, Chemical, or Mechanical); Master’s degree ideally.
15+ years of experience delivering medium / large capital projects within the pharmaceutical, biotechnology, or regulated life sciences industry.
Experience in small and large molecule API manufacturing is preferred.
Demonstrated track record delivering multiple large-scale pharmaceutical capital projects, including at least one project or program exceeding $25M in value.
Strong knowledge of cGMP, GxP, cleanroom design, pharmaceutical utilities, and validation principles.
Demonstrated leadership of large, cross-functional and multicultural project teams.
Extensive experience working with EPCMV/EPC contractors and complex supply chains.
Advanced project management skills including cost control, scheduling, risk management, and governance.
Excellent stakeholder management, communication, and executive reporting capabilities.
Professional Project Management certification (PMP, Prince2, or equivalent) strongly preferred.
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