Overview
The PM Group's Outsourced Technical Services (OTS) Department collaborates with leading global companies to identify top talent for their business needs. Partnering with us and our clients offers unparalleled opportunities to work with renowned brands.
We are currently recruiting a Project Engineer to support the management and execution of projects for a biopharmaceutical client in Cork. The Project Engineer will lead and support the execution of capital expenditure (CAPEX) projects at a biopharmaceutical manufacturing facility in Cork. This role involves managing the planning, design, procurement, construction, commissioning, and qualification phases to deliver projects on time, within scope, and ensuring compliance with regulatory and safety standards.
Responsibilities
1. Support or lead the end-to-end delivery of engineering CAPEX projects from concept to handover.
2. Develop detailed project scopes, objectives, schedules, budgets, and resource plans.
3. Coordinate with cross-functional teams, including manufacturing, quality, regulatory, and safety.
4. Collaborate with internal stakeholders and external engineering firms to develop design specifications, P&IDs, and layouts.
5. Ensure engineering designs meet GMP, safety, and environmental compliance requirements.
6. Provide technical expertise and troubleshooting during design, installation, and commissioning.
7. Prepare requests for proposals (RFPs) and evaluate supplier bids.
8. Manage vendor and contractor performance, ensuring adherence to technical specifications and project timelines.
9. Oversee the procurement of equipment, materials, and services required for project execution.
10. Supervise on-site activities, ensuring safe, efficient, and high-quality construction practices.
11. Develop and execute commissioning plans, including equipment testing, system integration, and performance verification.
12. Coordinate validation activities to meet GMP and regulatory requirements.
13. Monitor project budgets, track expenditures, and report on financial performance.
14. Identify and mitigate project risks, including scope changes and schedule impacts.
15. Prepare regular status updates, technical reports, and project documentation.
16. Ensure all projects adhere to local and international regulatory standards (e.g., FDA, EMA, OSHA).
17. Promote and maintain a strong safety culture throughout all project phases.
18. Perform risk assessments and ensure proper permits are obtained.
Qualifications
1. Bachelor's degree in Engineering (e.g., Mechanical, Chemical, Electrical, or related field).
2. 3-5 years of experience in project engineering, preferably in the biopharma, pharmaceutical, or related process industries.
3. Proven track record of delivering CAPEX projects within a GMP-regulated environment.
4. Strong knowledge of engineering principles, equipment, and systems used in biopharma manufacturing.
5. Proficiency with project management tools (e.g., MS Project, Primavera) and CAD software.
Desirable:
1. Master's degree or Project Management Professional (PMP) certification.
2. Familiarity with Lean Six Sigma or continuous improvement methodologies.
3. Knowledge of bioprocessing technologies, clean utilities, and automation systems.