LSC have a great contract opportunity for a Commissioning & Qualification 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 on Large Scale Projects and are ready for your next challenge this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Act as C&Q SME on the equipment within the area assigned.
- As such you will be executing with a view to leveraging testing from Commissioning and Qualification to PQ where possible.
- Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
- Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.
- Coordination of engineering sub-teams in the assigned suite during execution of IQ/OQ / Cycle Development & Validation activities.
- Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines / Revised Annex 1
- Experience with liaising with other departments - engineering, technical, operations and QA
- Experience with sterile processing and sterilisation technologies
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!
Apply via this advert or contact Sarah Ninan at +353 21 4771 329 if you have any more questions about this opportunity!