Process Qualification Engineer

Posted on: 30/05/2019
Ref: VAC-17351
  • Country: Ireland
  • Location: Cork
  • Industry: Commissioning/Validation
  • Discipline: C&Q Engineer
  • Employment Type: Contract
  • Duration: 52 weeks+


Job Description

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
PSQ Protocols
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.

Hot Jobs

Start typing and press Enter to search