Process Engineer
- Cashel, Co Tipperary
- Permanent
- Full-time
- Lead engineering activities for new product introductions and process improvements.
- Collaborate with product development to ensure manufacturability is embedded in design.
- Create and manage User Requirement Specifications for manufacturing equipment.
- Plan and execute equipment validation activities.
- Manage project schedules and support capital expenditure planning.
- Provide hands-on technical support across Manufacturing and Packaging areas.
- Lead root cause investigations and implement CAPAs.
- Raise and manage Change Controls to closure.
- Review and approve batch documentation, procedures, protocols, and reports.
- Support continuous improvement initiatives and cross-functional collaboration.
- Drive new product and component introductions through structured engineering input.
- Degree in Engineering or Science (Mechanical/Manufacturing preferred).
- 5-8 years' experience in a regulated manufacturing environment (Pharma/Medical Device ideal).
- Strong track record in equipment development, process validation, and troubleshooting.
- Solid understanding of GMP and regulatory standards (HPRA/FDA).
- Skilled in technical writing, presenting, and decision-making.
- Confident communicator who can work independently and in cross-functional teams.
- Experience with metered dose inhalation is an advantage.