Process Engineer

Process Engineer
Full Time Permanent position based on site in Hatfield
Competitive salary plus 12.5% Annual Bonus, 26 days holiday, Health and Dental Insurance and other excellent corporate benefits

As a Process Engineer you will provide operational and project engineering support to maintain reliable and compliant operation of the manufacturing and packaging equipment within the EMEA Knowledge Centre facility at Hatfield, ensuring that operations carried out within your area of responsibility are carried out in accordance with the requirements of the companies Quality System, GMP Guidelines and Industry Standards.

General 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.
* Resolves complex problems that do not have routine solutions
* Provide support to craft and technician grade personnel when technical issues are escalated.

Compliance
* Co-ordinate and participate in the development of risk assessment and method statements associated with specified work.
* Undertake Change Management, Deviation Investigation, Corrective Action and Preventative Action (CAPA) activities, root cause analysis (RCA) and continuous improvement projects.
* Participate in internal and external audits.
* Generate Standard Operating Procedures for Engineering and related activities.
* Participate in Critical Device/Instrument assessments and development of associated Critical Device lists.

Maintenance
* 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.
* Compile critical equipment information and hierarchies for input onto the site's controlling maintenance management system.

Projects
* 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.

If you are interested and feel you have the right skills or wish for a confidential discussion then please apply to this role.

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.

Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited and Grafton Professional Staffing Limited. We are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group UK website.