Reporting to the Project Engineering Manager, the Project Engineer is responsible for delivering capital engineering projects across their full life cycle within a highly regulated biopharmaceutical manufacturing environment.
The role involves managing third-party contractors, maintaining ownership of project budgets and schedules, and ensuring compliance with regulatory standards such as HPRA and FDA. The Project Engineer will work closely with cross-functional site teams to support technology transfer, plant efficiency and continuous improvement initiatives.
Key Responsibilities
- Deliver engineering and capital projects from design through commissioning and validation.
- Manage third-party contractors and external engineering partners.
- Own project budgets, schedules and cost control.
- Ensure compliance with regulatory, safety and engineering standards.
- Contribute to site capital planning and support funding approvals.
- Collaborate with manufacturing, quality and technology transfer teams.
- Lead continuous improvement initiatives to enhance plant performance.
- Support validation documentation, testing and regulatory readiness.
- Promote safe working practices and oversee contractor safety.
- Foster teamwork, knowledge sharing and a strong safety culture.
Qualifications & Experience
- Degree in Engineering or equivalent required.
- Minimum 5 years' experience delivering projects in a pharmaceutical or biopharmaceutical manufacturing environment.
- Experience in aseptic manufacturing and advanced biologics (e.g. cell culture, ATMPs) is advantageous.
- Project management accreditation (PMP or equivalent) is a plus.
- Strong understanding of regulated project delivery and construction safety.
- Proven ability to manage multiple priorities and tight timelines.
- Excellent communication, stakeholder management and documentation skills.
- Proficiency with MS Project or equivalent planning tools.
