Validation Engineer - Upstream OR Downstream - Biotech

Tipperary  ‐ Onsite
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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

Start date
August 2015
Duration
12 months
From
Quanta Consultancy Services
Published at
21.07.2015
Project ID:
948173
Contract type
Freelance
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