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:
Accountable for the following activities (but not exclusively):
* 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.
* Develop User Requirements Specifications (URS) for formulation systems required for Capital Projects, as well as support the development of URS for solution preparation systems.
* Engage with and manage design consultants, trade contractors, and equipment suppliers to ensure delivery meets all project requirements including URS, budgets, schedules, and deliverables.
* Review and approve all engineering documentation provided by design consultants, trade contractors, and equipment suppliers within the assigned scope of responsibility.
* Develop Issue for Bid (IFB), Issue for Tender (IFT), Issue for Purchase (IFP) work packages for vendors and contractors specific to solution preparation systems.
* Conduct technical and commercial bid evaluations for relevant work packages.
* Support the Capital Projects team in delivering projects on schedule and in line with agreed milestones, whether for a single project or a portfolio.
* Provide technical support for other design packages that interface with solution preparation systems.
* Communicate project status effectively to all relevant stakeholders and contribute to regular project updates.
* Oversee construction activities related to assigned work packages.
* Implement projects in compliance with site validation procedures.
* Prepare cost estimates in accordance with Capital Approval Request (CAR) requirements and manage budgets, purchase orders, and invoices to remain within approved funding.
* Manage various additional projects as required by the site.
* Coordinate and attend Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) within your scope.
* Support the management, training, and development of graduate engineers.
* Develop and execute the cleaning validation program.
* Lead the development of the Sterility Assurance Failure Mode Effect Analysis (SAFMEA) for assigned projects.
Principal Qualifications, Skills, And Experience Required:
* Degree in Process Engineering, Mechanical Engineering, or a related discipline.
* Minimum of 10 years experience working in a GMP-compliant Pharmaceutical or Medical Device environment, with a focus on Capital Projects implementation.
* In-depth knowledge of solution preparation and formulation processes in a fill-finish manufacturing setting.
* Proven experience in developing and executing cleaning validation programs.
* Strong background in establishing and delivering Capital Project Engineering processes and procedures to milestone targets within regulated industries.
* Demonstrated ability to lead change and implement improvements in Capital Project Engineering processes.
* Decisive, with strong communication and interpersonal skills.
* Experienced in managing a range of external stakeholders, including design, construction, equipment, and professional service providers.
* Proven ability to manage scope changes and project adjustments effectively.
* Skilled in both project and construction management.
* Capable of building collaborative working relationships across multidisciplinary internal and external teams.
* Self-starter, able to work independently with minimal supervision.
* Excellent time management and prioritization skills.
* High attention to detail and ability to maintain accuracy in fast-paced environments.
* Proactive and self-motivated, demonstrating initiative in task ownership.
* Desirable: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook).
For more information please contact Eoin McGreevy on 085 866 9484 or
email emcgreevy@aaeuro.com
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