Job Overview:
We are seeking a seasoned Project Engineer to lead the execution of projects for a biopharmaceutical client in Cork. The successful candidate will oversee the management and delivery of capital expenditure (CAPEX) projects at a biopharmaceutical manufacturing facility.
Key Responsibilities:
* Manage end-to-end delivery of Electrical / Instrumentation engineering CAPEX projects from concept to handover
* Develop detailed project scopes, objectives, schedules, budgets, and resource plans
* Coordinate with cross-functional teams, including manufacturing, quality, regulatory, and safety
* Collaborate with internal stakeholders and external engineering firms to develop design specifications, P&IDs, and layouts
* Ensure engineering designs meet GMP, safety, and environmental compliance requirements
* Provide technical expertise and troubleshooting during design, installation, and commissioning
* Prepare requests for proposals (RFPs) and evaluate supplier bids
* Manage vendor and contractor performance, ensuring adherence to technical specifications and project timelines
* Oversee the procurement of equipment, materials, and services required for project execution
* Supervise on-site activities, ensuring safe, efficient, and high-quality construction practices
* Develop and execute commissioning plans, including equipment testing, system integration, and performance verification
* Coordinate validation activities to meet GMP and regulatory requirements
* Monitor project budgets, track expenditures, and report on financial performance
* Identify and mitigate project risks, including scope changes and schedule impacts
* Prepare regular status updates, technical reports, and project documentation
* Ensure all projects adhere to local and international regulatory standards (e.g., FDA, EMA, OSHA)
* Promote and maintain a strong safety culture throughout all project phases
* Perform risk assessments and ensure proper permits are obtained
Requirements:
* Bachelor's degree in Engineering in Electrical or Instrumentation
* 3-5 years of experience in project engineering, preferably in the biopharma, pharmaceutical, or related process industries
* Proven track record of delivering CAPEX projects within a GMP-regulated environment
* Strong knowledge of engineering principles, equipment, and systems used in biopharma manufacturing
* Proficiency with project management tools (e.g., MS Project, Primavera) and CAD software
* Master's degree or Project Management Professional (PMP) certification
* Familiarity with Lean Six Sigma or continuous improvement methodologies
* Knowledge of bioprocessing technologies, clean utilities, and automation systems