Process Engineer - GMP
Are you a Manufacturing or Process Engineer with experience working in pharmaceutical manufacturing?
Looking for a new challenge in a fast growing business?
Our client is a fast growing manufacturing business with its routes linked to life saving research. With this in mind they are currently looking to recruit a number of engineers to their team. This role will be responsible for providing engineering support within a highly regulated GMP environment.
This role will involve working as a technical expert on a number of projects within the engineering group working across a variety of other departments to oversee the smooth day to day operation along with the long term continuous improvement strategies for the business.
- 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 requirements.
- 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 supported by the Process Engineering Manager.
- 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 non-conformance system, for failures/performance issues.
- Represent Engineering as Project Engineer and system expert on capital projects.
Experience / Expertise:
- Degree in Process or Chemical Engineering
- 4 years post graduate work experience ideally with a pharmaceutical business
- Knowledge of working to GMP standards
- Knowledge of validation, capital projects and equipment commissioning
If you are interested in applying for this role please click apply now!
Harris Lord is acting as an employment agency for this role.
Keywords: process, production, manufacturing, engineering, process engineer, manufacturing engineer, chemical engineering, GMP, cGMP, FDA, engineer, CAPEX, capital projects,