Description
Senior Validation Engineer URGENTLY required for new build Biopharmaceutical facility based in Ireland.We are looking for candidates experienced within the biopharma sector who ideally have previous start up knowledge and have worked with process equipment within an upstream environment (Bioreactors, Cell Culture, Harvest vessels etc)
You will be leading a team of Validation Engineers to work on the qualification of the new upstream equipment.
Duties and Responsibilities will include:
Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ, Cleaning Validation protocols; drive approval of same.
Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
Interface with Regeneron Commissioning and Process Sciences teams.
Support CIP and SIP validation programs as necessary.
Support Regeneron Management in Project delivery
JOB REQUIREMENTS:
Proven BioTech experience in the given area
Lead position: 5 years BioTech C&Q experience, of which 2 years as a working Lead Team Member position
Experience in Document Preparation and Execution
Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing
Have Troubleshooting and analytical mindset.
Degree Educated: B.Sc, B.Eng.
This is a 12 month + contract assignment.