Job Reference: J5634004
Updated On: 04/11/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Technical Specialist - Production Engineering to join a leading Biopharmaceutical company based in the Hertfordshire area. As the Technical Specialist - Production Engineering you will be responsible for the technical support covering major investigations, fault-finding, continuous improvement projects, training and planning. You will provide direction and expertise to the engineering function – in order to develop the knowledge and capability of the operations teams.
Key Duties and ResponsibilitiesYour duties as the Technical Specialist - Production Engineering will be varied however the key duties and responsibilities are as follows:
1. As the Technical Specialist - Production Engineering you will support the planning and scheduling of investigation work within Engineering. Complete major incident investigation. Create and review technical investigation reports. Support the identification, recording and trending of Functional Failure and Failure Mode data. Take ownership of DRs including the creation, investigation and close-out.
2. You will carry out reviews of PM effectiveness and provide technical support to validation and qualification activities on site. You will act as subject matter experts during regulatory inspections.
3. As the Technical Specialist - Production Engineering you will create, review and update SOPs and BEMPs. Develop and deliver technical training. Develop and maintain the Engineering training matrix, including training records and the version control spreadsheet.
4. You will support by raising, managing and providing technical support to change controls. Assisting in all aspects of Projects, including URS development, design work and approvals.
Role RequirementsTo be successful in your application to this exciting opportunity as the Technical Specialist - Production Engineering we are looking to identify the following on your profile and past history:
1. Relevant qualification, NVQ or HNC/HNC in Mechanical/Electrical Engineering. Degree or Chartered Engineer would be preferable.
2. Proven industry experience of Aseptic Filling Lines, Centrifugation, Lyophilisers, Autoclaves, Sterilisation and Depyrogenation Systems, Clean Room Technology, Ultra-Filtration, and Packaging Lines.
3. A working knowledge and practical experience with Quality Management Systems within a Pharmaceutical GMP Environment
Key Words: Engineer, Engineering, Hertfordshire, GMP, Technical Specialist, SOPs, Biopharmaceutical
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