Our client, a medical device company in Clare are currently looking to recruit a Validation Engineer (BV) for their site.
Typical related responsibilities will include but are not limited to the following:
- Write, review, approve and execute Validation Protocols for the Blood Virus Project (for Equipment, Utilities, Processes, Cleaning, Test Methods, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
- Write, review and approve Validation Reports ensuring compliance to all relevant global and local quality and validation procedures/standards
- Participate in the preparation of User Requirement Specifications to ensure that they comply with Validation and GMP requirements as required
- Execute/Co-ordinate Re-Validation activities as required
- Review/Approve change controls and assess impact of changes that affect validated systems and define validation requirements
- Represent Validation at both internal and external audits.
- Participate in, and Support the operation of Validation Visual Daily Management
- Support DBS improvement initiatives in Validation Team including PSP and Kaisen events
- Co-ordinate/Supervise Contractor Qualification activities
- Administer Validation files and ensure that Validation Logging System is maintained, tracking Validations and Validation Files and ensuring full record accessibility.
- Third level degree in science or engineering in addition to 3 years’ relevant experience in a GMP/FDA/IMB regulated environment.
- Experience of formal regulatory audits (e.g. FDA/IMB) and good working knowledge of statistics, desirable.
For further information on this Validation Engineer (BV) role in Clare please contact Karl Lippett on 086 1070950 / firstname.lastname@example.org
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