Job Reference: J5634844
Updated On: 26/04/2021
Status: Now Interviewing
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Role OverviewAn exciting opportunity has become available for a Validation Technical Operations Engineer to join a leading pharmaceutical manufacturing organisation based in West Yorkshire. As the Validation Technical Operations Engineer you will be responsible for the development and execution of qualification packages, validation plans, test scripts and protocols for all key pharmaceutical manufacturing systems.
Key Duties and ResponsibilitiesYour duties as the Validation Technical Operations Engineer will be varied however the key duties and responsibilities are as follows:
1. Ensuring the implementation and life cycle management of Operation systems to meet manufacturing regulatory guidelines such as Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practices (GAMP).
2. Responsibility for the validation life cycle of key manufacturing systems including, HVAC, Product Isolators, Filling Equipment, Manufacturing Equipment, Labelling and Packaging Systems and Cleaning Systems.
3. Writing system project documentation, including; Tender documents, supplier responses and supplier audit details. As well as writing policies and procedures. Writing and executing system validation documentation including; VAP, URS, UAT, IQ/OQ and PQ.
4.Acting as the System Owner / Administrator for assigned designated systems and providing technical advice and recommendations to stakeholders as required.
Role RequirementsTo be successful in your application to this exciting opportunity as the Validation Technical Operations Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree or equivalent qualification in a Scientific or Engineering discipline.
2. A good understanding of the engineering principles underpinning key manufacturing systems. Experience of working in a GMP pharmaceutical environment or other similarly regulated industry
3. Extensive experience of writing and executing validation protocols and a good understanding of GMP are essential.
Key Words: Validation | Engineer | Pharmaceutical | Engineering | Manufacturing | Production | Packaging | GMP | GAMP | IQ | OQ | PQ |
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