AA Euro Group has been retained by a Leading Global Pharmaceutical Company to search for a Lead Project Engineer for their Cork Operations.
Main Duties And Responsibilities:
1. Act as the Lead Engineer and Subject Matter Expert (SME) in the solution preparation field for the new project site, while also serving as a Senior Project Engineer within the Capital Projects Department.
2. Develop User Requirements Specifications (URS) for formulation systems required for Capital Projects, as well as support the development of URS for solution preparation systems.
3. Engage with and manage design consultants, trade contractors, and equipment suppliers to ensure delivery meets all project requirements including URS, budgets, schedules, and deliverables.
4. Review and approve all engineering documentation provided by design consultants, trade contractors, and equipment suppliers within the assigned scope of responsibility.
5. Develop Issue for Bid (IFB), Issue for Tender (IFT), Issue for Purchase (IFP) work packages for vendors and contractors specific to solution preparation systems.
6. Conduct technical and commercial bid evaluations for relevant work packages.
7. Support the Capital Projects team in delivering projects on schedule and in line with agreed milestones, whether for a single project or a portfolio.
8. Provide technical support for other design packages that interface with solution preparation systems.
9. Communicate project status effectively to all relevant stakeholders and contribute to regular project updates.
10. Oversee construction activities related to assigned work packages.
11. Implement projects in compliance with site validation procedures.
12. Prepare cost estimates in accordance with Capital Approval Request (CAR) requirements and manage budgets, purchase orders, and invoices to remain within approved funding.
13. Manage various additional projects as required by the site.
14. Coordinate and attend Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) within your scope.
15. Support the management, training, and development of graduate engineers.
16. Develop and execute the cleaning validation program.
17. Lead the development of the Sterility Assurance Failure Mode Effect Analysis (SAFMEA) for assigned projects.
Principal Qualifications, Skills, And Experience Required:
1. Degree in Process Engineering, Mechanical Engineering, or a related discipline.
2. Minimum of 10 years’ experience working in a GMP-compliant Pharmaceutical or Medical Device environment, with a focus on Capital Projects implementation.
3. In-depth knowledge of solution preparation and formulation processes in a fill-finish manufacturing setting.
4. Proven experience in developing and executing cleaning validation programs.
5. Strong background in establishing and delivering Capital Project Engineering processes and procedures to milestone targets within regulated industries.
6. Demonstrated ability to lead change and implement improvements in Capital Project Engineering processes.
7. Decisive, with strong communication and interpersonal skills.
8. Experienced in managing a range of external stakeholders, including design, construction, equipment, and professional service providers.
9. Proven ability to manage scope changes and project adjustments effectively.
10. Skilled in both project and construction management.
11. Capable of building collaborative working relationships across multidisciplinary internal and external teams.
12. Self-starter, able to work independently with minimal supervision.
13. Excellent time management and prioritization skills.
14. High attention to detail and ability to maintain accuracy in fast-paced environments.
15. Proactive and self-motivated, demonstrating initiative in task ownership.
16. Desirable: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Consulting
Industries
Construction and Pharmaceutical Manufacturing
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