LSC have great contract opportunity for a Validation Engineer to join a global Biopharmaceutical company in Carlow. This is a state of the art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia and infectious disease. The site is less than ten years old and has been fitted with the most up to date manufacturing technology and best practices and is truly a “state-of-the-art” facility. Site activities include the development of next generation oncology products, Formulation of Vaccines & Biologics, Fill finish / Vial filling, Packaging and Global distribution.
If you have minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
o Act as validation SME on the equipment within the area assigned. As such you will be leveraging testing from Commissioning and Qualification.
o Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
o Implementing the requirements as outlined in the site / project Validation Master Plan.
o Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
o Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o SME on Equipment Validation on any of; CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels
o Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines
o Experience with liaising with other departments – engineering, technical, operations and QA
o Experience with sterile processing and sterilisation technologies
o Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
o Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
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!
To apply, submit your CV via this advert or contact Kathy Gillen at LSC on 021-4777329 if you have anymore questions about this Validation Engineer opportunity!