We are seeking an experienced Senior Equipment Engineer to support a major manufacturing expansion for our pharmaceutical client in Dublin. This role will focus on the engineering implementation and operational setup of new syringe filling, inspection, washing, and formulation systems within a sterile fill-finish environment.
Key Responsibilities
- Support all engineering and equipment activities for the installation and startup of syringe filling, inspection, washing, and formulation systems.
- Lead and participate in FAT, SAT, commissioning, and qualification phases to ensure equipment readiness for GMP manufacturing.
- Coordinate equipment setup, calibration, and functional testing, ensuring alignment with site engineering and quality standards.
- Collaborate closely with Manufacturing, Quality, Automation, PD, and Global Engineering to ensure seamless integration of new systems.
- Support change control, validation, and documentation activities in compliance with cGMP and site procedures.
- Contribute to the development of preventive maintenance and calibration programs for new equipment.
- Provide technical troubleshooting during installation and startup, ensuring timely resolution of engineering issues.
- Prepare and review engineering deliverables including specifications, FAT/SAT protocols, and handover packages.
- Work flexibly, including extended days or two-cycle shift coverage during critical commissioning and qualification phases.
Qualifications & Experience
- Bachelor's Degree (or higher) in Mechanical, Electrical, Chemical, or related Engineering discipline.
- 4+ years' experience in a GMP manufacturing or project engineering role within the biopharmaceutical or sterile fill-finish sector.
- Demonstrated experience with syringe filling, inspection, or formulation systems.
- Proven capability in equipment commissioning, qualification, and validation.
- Strong knowledge of GMP, regulatory, and quality systems.
- Hands-on experience managing FATs, SATs, and vendor interactions.
- Excellent communication, teamwork, and problem-solving skills.
- Self-starter with the ability to work in a small project team and adapt to evolving priorities.
- Flexibility to support on-site and extended-hour work during key project milestones.
