Job Description
Required to support sterilization process requalification?s, new/changed product adoptions, process changes, and corporate lean business practice initiatives.
The successful candidate will provide technical excellence in the field of Sterilization. Independently, or as a member of a team, the hire will develop, direct, and execute plans for sterilization projects.
This is a permanent role in Cork.
Key responsibility:
Compiles and analyzes validation data to establish technical specifications for sterilization of products to cGMP?s of all regulatory agencies (including FDA, etc.).
Responsibilities of Sterilisation Engineer:
Manages sterilization activities to support product recertification projects at each site
Manages product and process sterilization validations
Key participant in the development and validation of new sterilization cycles.
Key role in qualification of new sterilization vendors and facilities
Manage sterilization continuous improvement projects at site and contractor facilities
Provide assistance and support to the sterilization, regulatory and quality groups as required.
Designs and coordinates engineering tests and experiments related to sterilization.
Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
Responsible for sterilization evaluation engineering documentation.
Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
May train and/or provide work direction to more junior scientists or engineers.
Requirements for Responsibilities for Sterilisation Engineer:
Bachelor?s degree in Microbiology or related discipline, Advanced degree preferred
5+ years of experience in roles related to Sterilization and Microbiology
Device requirements and Quality System standards
Experience in product and process validation for Ethylene Oxide, Gamma, E-Beam and steam sterilization methods
Experience/understanding in sterilization methods for re-useable med devices a plus
Project Management experience is desirable
Please phone Larry on 01-2302400 / 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.