We are actively recruiting for a delivery-focused Project Engineer to join a Tralee based site. In this dynamic role, you will drive business-critical CAPEX and operational projects from initial concept through to final qualification and handover. This position offers full lifecycle ownership, budget accountability, and cross-functional leadership within a progressive culture that values integrity, diverse ideas, and intelligent risk-taking.
As Project Engineer you will plan, execute, and deliver essential engineering projects that support biopharmaceutical manufacturing, facility upgrades, technology transfers, and process improvements. You will be responsible for ensuring all projects meet strict safety, quality, regulatory, and business requirements while coordinating cross‑functional teams and external vendors to guarantee successful project delivery.
Role and Responsibilities:
- Lead end‑to‑end engineering projects including scopes, schedules, budgets, risks, handovers, and reporting.
- Provide engineering expertise across equipment, utilities, automation, and process systems; develop URS/design docs; review drawings and FAT/SAT protocols.
- Collaborate with QA, Validation, Manufacturing, Supply Chain, EHS, and contractors; support design reviews, hazard assessments, and change controls.
- Ensure GMP/GDP, FDA, EMA, ICH compliance; support commissioning, qualification, FAT/SAT and maintain audit‑ready documentation.
- Prepare capital justifications, manage CAPEX budgets, track costs, and support procurement and vendor negotiations.
- Identify and mitigate project risks, manage documentation and tracking tools, evaluate outcomes and drive continuous improvement.
Skills, Attributes & Experience:
- Bachelor's degree in Engineering or significant relevant experience.
- Experience managing pharmaceutical engineering projects, equipment vendors, and cross‑functional teams.
- Strong knowledge of GMP, validation, and pharmaceutical manufacturing.
- Proficiency in project management tools (e.g., MS Project, Primavera).
- Excellent analytical, leadership, organisational and troubleshooting skills.
- Proven capability managing multiple projects in a regulated environment.
- Deep understanding of the project lifecycle from concept through to qualification
