Competitive Salary & Benefits
Our International pharmaceutical client is looking for an experienced Process Engineer to provide operational and project engineering support in order to maintain reliable and compliant operation of the manufacturing and packaging equipment. This role is also responsible for ensuring that operations carried out within specific areas of responsibility are carried out in accordance with the requirements of the Quality System, GMP Guidelines and Industry Standards.
Main duties and responsibilities:
* Provide engineering technical expertise to support the operations of site in accordance with Good Manufacturing Practice (GMP) and Good Engineering Practice (GEP).
* Optimisation of manufacturing and packaging equipment to ensure reliability and efficiency in terms of cost and availability.
* Deliver improvements to equipment reliability and availability, maintaining metrics and KPI to demonstrate performance.
* Co-ordinate and participate in the development of risk assessment and method statements associated with specified work.
* Participate in internal and external audits.
* Generate Standard Operating Procedures for Engineering and related activities.
* Define maintenance regimes for process equipment taking account of manufacturers recommendations, production drivers and GMP and GEP requirements.
* Management of external contractors for the execution of specialist maintenance activities, including feeding back and monitoring on performance.
* Define equipment spares requirements, identifying specifications, sources of supply and stock levels.
* Advise on equipment selection, participating in detailed design development and working with technical services to ensure robust solutions are implemented to ensure reliability.
* Leads or coordinates project planning, resourcing, reporting, commissioning activities for engineering projects.
* Lead commissioning activities to certify equipment will operate in accordance with design intent and to ensure installation and qualification tasks are executed smoothly.
* Support technical services in the qualification and validation of equipment.
Skills & Experience required:
* HNC/HND/Degree qualified in a relevant engineering discipline (e.g., automation, chemical, electrical, mechanical engineering)
* EngTech / IEng or working towards professional status.
* Project Management training - CAPM / PMQ (or equivalent).
* Understanding / training in Lean Six Sigma
* Professional membership - IMechE, IET, PMI, APM, ISPE (or similar)
* Practical experience of GMP manufacturing, packaging processes &/or equipment within MHRA / FDA regulated facilities.
* Demonstrable awareness of commissioning, qualification, and validation project activities.
* Comfortable with technology.
If you are interested in this role and feel that you have the right skills then please click apply.
For further details, please contact us on 01707 247259
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.