Manufacturing engineer
CREGG are currently hiring a Manufacturing Engineer to work onsite with a leading medical device multinational client in Galway. Call Stephen Coen 0861030418 Email: stephencoen@cregg.ie
Your Role:
Your primary responsibility will be within the Centralised Sterilization & Packaging Production Unit, supporting the Sterilization area. This offers you an exciting opportunity to contribute towards the growth and expansion of this newly formed Production Unit. This specific role is for a Manufacturing Engineer to support an existing Ethylene Oxide sterilisation Sterilization area while in parallel qualifying and validation of new equipment due to expansion. This is fixed term contractor role, 18 months.
Within this role you will:
- Evaluate manufacturing processes based on quality criteria, such as efficiency and speed
- Under broad supervision / guidance you will compile and analyse data to establish performance standards for newly implemented or modified products and processes.
- Work within a growing Ethylene Oxide Sterilization area in developing, trouble shooting, standardising, and improving existing production methods and procedures.
- Perform equipment qualifications and validations, including report writing etc.
- Design, specify, manufacture, test and document production equipment, changes and improvements.
- Champion safety practices and improvements in the area.
- Liaising with other key functions: Global Sterilization Assurance, Quality, Facilities, Health and Safety, MIO.
- Project manage improvement and new cycle projects.
- Review, create, optimise Sterilization cycles.
- Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements.
- Work with EHS to evaluate new equipment, process and chemicals for environmental impact and effect in order to eliminate or lessen such impacts or effects.
- Work closely with and give technical guidance to Associate Engineers and Technicians.
- Actively promote and participate in a cross-functional teamwork environment.
- Demonstrate a primary commitment to patient safety and product quality and understand and comply with all the regulations governing the quality systems.
What we need from you:
- A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
- A minimum of 3-4 years’ experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
- Demonstrated working knowledge of the set-up, maintenance and troubleshooting of Ethylene Oxide sterilisation systems and cycle validations is an advantage.
- Equipment validation experience.
- Project Management experience desirable but not essential.
- We would like you to be a team player and someone who is fully motivated to achieve and demonstrate best practices in line with the department and site objectives.