Job Description
Our client, a world class healthcare manufacturer based in Galway, now seeks a Sterilisation Engineer to be a key player in the development and establishment of a new sterilisation facility, including equipment processes, procedures, validations, audits, ready for commercial manufacture in a GMP, FDA regulated environment.
This hire will become the Subject Matter Expert (SME) for Sterilisation, using their knowledge and expertise for the set-up, maintenance and troubleshooting of Ethylene Oxide sterilisation systems and cycle validations, chambers, chillers, etc. This hire will be provide expertise on FDA, ISO, MDD and and/or quality requirements associated with developing medical devices.
The ideal person will be a person suit a pro-active, energetic, self-assured professional who seeks a career path to move into a leadership role. Proven ability to collaborate, influence and develop positive interpersonal relationships is preferred.
Note: this hire will move to the US for an initial 6-9 month period for training and development to become SME.
Responsibilities for Sterilisation Engineer:
Analyses process, product, material or equipment specifications and performance requirements within the new Galway site Sterilisation Facility.
Under broad supervision / guidance compiles and analyses operational, test and experimental data to establish performance standards for newly implemented or modified products / processes.
Summarises, analyses and draws conclusions from test results leading to effective technical resolution.
Troubleshoots new products / process working closely with product development.
Continually seeks to drive / improvements in process design, layout and operational performance of both the Sterilisation and Packaging operations.
Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
Actively promotes and participates in a cross-functional teamwork environment.
Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
Gives technical guidance to Associate Engineers and Technicians.
Requirements for Sterilisation Engineer:
Honours Bachelor’s Degree (HETAC Level 8) qualified, ideally in Engineering, Science or equivalent.
4+ years’ experience in a relevant manufacturing area.
Working understanding of US and International regulations associated with all modes of sterilization
Experience with IQ, OQ and PQ processes
Experience with lean manufacturing and Sterilization Best Practices
Strong trouble shooting and problem solving skills
Excellent technical capabilities, communication skills, teamwork abilities and initiative.
Industry experience in combined Ethylene Oxide sterilisation and medical device packaging technologies a distinct advantage.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
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