Computer System Validation Engineer / CSV - Pharma

Job type:
Start date:
Quanta Consultancy Services
County Limerick
Published at:
flag_no United Kingdom
Contact person:
Lee Mitchell
Project ID:

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Exciting new build Biopharmaceutical project based in Ireland, offering long term contract assignments, is looking for experienced Computer System Validation Engineers.

US owned company - voted top 5 innovative company to work for and a global leader within the Pharmaceutical sector - has ventured into Europe and has built a new €400million facility.

We are looking for experienced Computer System Validation Engineers to 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 varous 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/Med Device environment experience

• Experience in Document Preparation and Execution

• Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.

• Good technical knowledge of equipment and the concepts of BioTech manufacturing