Headcount Solutions requires a Microbiologist for a clients Medical Product Manufacturing facility.

The successful candidate will be degree-qualified in Microbiology (or equivalent), with a minimum 3 years experience in a regulated industry. Familiarity with microbiological aspects of GMP regarding sterile medical devices and experience of conducting GMP audits, is essential.

Please note: This is a contract role of circa 2 years duration.

Principal Responsibilities:

• Implement the microbial assurance aspects of the Quality System.
• Carry out regular microbial monitoring of all clean room facilities and water systems, to analyse the results and recommend corrective action where appropriate.
• Oversee/co-ordinate use of all microbial services.
• Review and develop procedures for all microbial assurance activities.
• Carry out regular internal auditing of all clean room facilities and other areas.
• Implement the GMP training programme for clean room and other appropriate staff.
• Source alternative sterilisation technologies for the facility that could be applied to client’s products.
• Be a member of New Product Development teams and undertake cleaning, microbial, sterilisation validation as required.
• Responsible for the release of sterile products.
• Audit the sterilisation subcontractors, contract laboratories and clean room clothing suppliers.
• Validate the microbial aspects of new products.
• Support specific projects as allocated by the Microbiology Team Leader.

For further information, please contact Michael McQuade on 086-0435195 / 01-6905040 or submit cv in strictest confidence to jobs@headcount.ie