Project Engineer
We are currently recruiting a Project Engineer to support the management and execution of projects for a biopharmaceutical client in Cork.
Key Responsibilities:
* Lead and support the end-to-end delivery of 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 (e.g., Mechanical, Chemical, Electrical, or related field).
* 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.
Desirable:
* 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.