SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
Why SimoTech
What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, benefits, career progression, educational support and much more.
SimoTech have an opportunity for an experienced Senior Project Manager to work with a leading multinational Biopharma client based in Cork, Ireland.
The Senior Project Manager will be responsible for the full lifecycle delivery of major capital investment projects within a GMP environment, ensuring safe, on time, and on budget execution of complex manufacturing, cleanroom, utilities, and infrastructure works in full regulatory compliance, while working closely with a variety of business units from Engineering, to Supply Chain and Finance.
This role presents the potential opportunity for international travel of up to 20-30%, which may include weekends and multi week stays.
Key Responsibilities
Act as main point of contact for capital investments leading external 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 accurate project 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 partners.
Lead contractor and supplier management including selection, contract negotiation, performance management, and change.
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 health & safety 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 term capital planning and strategic manufacturing footprint initiatives.
Key Requirements
Bachelor’s degree in engineering (Process, Chemical, or Mechanical); Master’s degree ideally.
Over 15 years of experience delivering large scale capital projects within the pharmaceutical, biotechnology, or regulated life sciences industry.
Professional Project Management certification (Eg: PMP, Prince2) highly preferred.
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 external vendors and complex supply chains.
Advanced project management skills including cost control, scheduling, risk management, and governance.
Excellent stakeholder management, communication, and executive reporting capabilities.
What SimoTech Can Offer
Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
Opportunity to work with large corporate clients on exciting capital projects.
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