6 months ago
We are currently working with a leading Pharmaceutical organisation, based in the UK who are currently looking to expand their team quire rapidly due to a large influx in project work and are looking to grow the department out with a number of Process Engineers. This group is specifically responsible for all engineering support within GMP facilities, including specialising within clean rooms, critical utilities, production equipment, facilities and capital project work.
The successful individual will be a technical expert for all engineering utility systems, under the GMP environment and responsible for managing small projects and initiatives for the utility systems ensuring they adhere to GMP guidelines.
Other responsibilities include:
- To monitor Utilities equipment trend data as provided by the computerised maintenance management system and liaison with the maintenance teams/users, to recommend and manage process improvements/initiatives, and when required prepare justifications for submission within the appropriate capital budget.
- Project Manage small business critical GMP projects as delegated by the Process Engineering Manager in accordance with the GMP Capital Project procedure.
- Deputise for the Process Engineering Manager providing technical guidance and training to the wider Pharmaceutical engineering team and administering business process related tasks through the computerised maintenance management system.
- Represent the Engineering function at BSI, MHRA and FDA audits as subject matter expert for Utilities
- To be responsible for the writing, and review of User Requirement specifications, SOP’s, and generation of design documentation related to Utilities systems and other equipment within the GMP envelope.
- Review and Approval of Engineering technical regulatory documents as required to support the Engineering function including review and approval of Safety related documents such as pressure systems written schemes of examination.
- Responsible for troubleshooting and liaising with maintenance technicians, engineers and users to establish the root cause, develop and manage appropriate corrective action plans and report through the nonconformance system, for failures/performance issues.
- Represent Engineering as Project Engineer and system expert on capital projects.
- Masters degree in Process or Chemical Engineering
- Ideally chartered engineering status
- Extensive experience within engineering an operational design role in the pharmaceutical industry
- Strong GMP documentation experience
- Experience with regulatory audits
- Experience and knowledge within facilities, equipment and GMP critical utilities operation, commissioning and validation.
- Experience of working within a GMP quality system, change control, CAPA, deviations and documentation management