LSC have a 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.
If you have minimum 3 years process equipment C&Q/ Validation experience 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 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 aim to leveraging testing from Commissioning and Qualification where possible.
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 and participation in 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; SIP / Autoclaves
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 validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
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 Conor Dolan at LSC on 021-4777329 if you have anymore questions about this Validation Engineer opportunity!