Description
Exciting new build Biopharmaceutical project based in Ireland offering long term contract assignments are looking for experienced Validation Engineers with either UPSTREAM or DOWNSTREAM equipment experience.US owned company - voted top 5 innovative company to work for and a global leader within the Pharmaceutical sector have ventured into Europe and a new build €400million facility has been built
We are looking for experienced Validation Engineers with experience of ANY of the following equipment within a Biopharmaceutical environment:-
Filtration, Purification, Fermentors, cell culture, harvest vessels, bioreactors, chromatography.
You will be required to carry out the day-to-day authoring and execution of Validation activities, working with the broader QA Validation and Automation Teams to ensure validation deliverables are completed per schedule.
As this is a start-up project you will be required to work across various areas and gain exposure to multiple systems
Key Responsibilities will include:-
• Completion of Document Preparation and Field Execution activities for the initial Qualification and Validation of the facility. • Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval. • Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ, • Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same. • Interface with the client on Commissioning and Process Sciences teams. • Support the client Management in Project delivery. • The role is a lot of the hands on work - writing wrap (close off) around protocols, execution vendor documentation, assessing deviations, traceability matrix generation. Key Requirements: • Strong background within the Biopharmaceutical/Pharmaceutical environment experience • Experience in Document Preparation and Execution • Good technical
knowledge of equipment and the concepts of BioTech manufacturing