We are seeking an experienced Project Engineer with a strong background in pharmaceutical design and project delivery to join the client-side engineering team supporting a fast-track Fill/Finish facility expansion in South Dublin.
This role is part of a high-performing project delivery team responsible for the design, coordination, and implementation of new formulation and component preparation systems as part of a large-scale drug product facility build. The position is ideal for a technically strong engineer with a background in design execution, vendor management, and project delivery within a highly regulated environment.
Key Responsibilities
- Act as a client-side design engineer, supporting the delivery of formulation and component preparation systems within a large-scale Fill/Finish facility.
- Provide technical leadership and design input across all project phases - Basis of Design, Detailed Design, Commissioning, and Qualification.
- Coordinate and integrate design activities between internal engineering teams, design partners, and process equipment vendors.
- Participate in vendor selection, technical reviews, and FAT/SAT activities, ensuring systems meet technical and quality standards.
- Offer direction and guidance to cross-functional teams on design execution, schedule, and cost management to achieve project milestones.
- Review and approve design documentation including URS, SDS, equipment specifications, and design reports.
- Support automation, commissioning, and validation teams with technical input related to equipment and system design.
- Provide oversight during construction and installation, ensuring design intent is maintained and delivered.
- Collaborate with site functions including Maintenance, Calibration, and Metrology to ensure seamless system integration and lifecycle management.
Qualifications & Experience
- Minimum 5 years' experience in pharmaceutical or biopharmaceutical project engineering, ideally with exposure to both design and project delivery phases.
- Strong understanding of process equipment, formulation systems, or clean utility design (direct formulation experience advantageous but not essential).
- Proven ability to manage vendors and third-party partners in a large-scale capital project environment.
- Experience supporting commissioning, qualification, and validation (CQV) activities.
- Excellent communication and stakeholder management skills, with the ability to influence and guide multidisciplinary teams.
- Degree in Chemical, Mechanical, or Process Engineering, or equivalent technical discipline.
- Previous experience working in a highly regulated cGMP environment.
- Flexibility to travel for vendor FATs (EU/US) as required.
