Computer System Validation Engineer/CSV - Pharma

Job type:
Start date:
July 2015
12 months +
Quanta Consultancy Services
Published at:
flag_no Ireland
Project ID:

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Exciting new build Biopharmaceutical project based in Ireland offering long term contract assignments are 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- have ventured into Europe and has built a €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