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 Bachelor of Engineering or Science Degree in Engineering or Technology related discipline and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
There are 4 broad technical areas that will require the leadership of experienced, energetic and committed engineers -
- Sterilisation & Temperature Mapping - Autoclaves & CTUs
- Cleaning - Parts Washer
- Vial and Syringe (and cartridge) filling operations - Glass handling, Tray & Tub handling, Drug Product Filling and Parenteral Product Visual Inspection.
- Vial and Syringe Sterility operations - Isolators, VHP
- Fill Finish ancillary equipment - FIT, GIT, Tube Welders/ Sealers
- The successful candidate will need to have demonstrated in-depth experience in 3 or more of these areas.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects
- SME on Equipment Validation on any of; Parts Washer / Autoclaves / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities - Transfer Panels & Formulation / Visual Inspection/ Single Use Technologies
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines / Revised Annex 1
- Experience with liaising with other departments - engineering, technical, operations and QA
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 Siobhan Cummins if you have any more questions about this opportunity!