LSC have a great contract opportunity for a Process Qualification Engineer to join a leading Global Pharmaceutical company based in Cork. The Cork campus has produced small molecule API for over 30 years and has built a new Biotechnology facility which will deliver the next generation of products to the global market.
The Process Qualification Engineer will be responsible for:
o Generate documentation relating to all aspects of Process Support Qualification (PSQ) including:
PSQ Master Plans & Integration of User Requirements into Testing
Mixing Studies, kla Studies, Media Challenges, Unit Operations, Column Packing Trials etc
Qualification Summary reports
o Execute PSQ activities on the new systems and equipment located in the manufacturing facilities.
o Ability to support C&Q activities if required, including but not limited to DQ, RV, IV, SSP, FT, IQ, OQ.
The Process Qualification Engineer requires:
o Relevant degree preferably in a scientific or engineering field. Ideally a minimum of 3 – 4 years of work experience in Biotech API supporting Equipment and Process Qualification.
o Technical knowledge of biotech equipment (Bioreactors, Chromatography Columns, TFFS, CIP skids, Freezers, etc.) and associated Commissioning and Qualification (C&Q) requirements
o Knowledge of Biotech manufacturing processes and understanding of production schedules
o Knowledge of relevant FDA and EU regulations relating to Qualification and Validation in Biotech manufacturing
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!
If this role is of interest, please call Ruth at LSC on 021 4777 329 or apply directly through this advert.