LSC have a great contract opportunity for Cleaning Validation Technical Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Develop and implement/update cleaning strategies for fixed and mobile parts.
- Development/update and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
- Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required.
- Generate and execute cleaning validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.
- Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of technology transfer, and routine manufacturing timelines in the context of cleaning verification/validation.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
- 1 - 3 Years of Experience
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 LSC on 021-4777329 if you have any more questions about this role!