LSC have an exciting contract opportunity for a Cleaning Validation Engineer to join a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT – CLEANING VALIDATION ENGINEER KEY RESPONSIBILITIES:
o Development of Cleaning and Sterilisation Validation Strategy, Validation Plans, Protocols and Reports for all cleaning and sterilisation equipment and processes for a Sterile Fill Finish Facility.
o Ensure all aspects of Cleaning and Sterilisation Validation adhere to required policies and procedures, including safety and training.
o Load Configuration and cycle development Cleaning Validation and Performance Qualification.
o Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
o Pre-approve and post-approve vendor protocols and assessments from a quality system documentation perspective for Autoclaves, CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
o Handle biological indicators and perform thermal mapping executions with Ellab and LIVEs validation hardware
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o A third level qualification in Science, Engineering or a relevant Quality discipline.
o Minimum 4-6 years’ experience in a similar role.
o Cleaning and Sterilisation Experience essential
o Component Preparation Commissioning Experience an advantage
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
If this Cleaning Validation Engineer role is of interest, please call Kathy at LSC on 021 4777 329 or apply directly through this advert