Process Engineer Mechanical / Manufacturing

The Process Engineer will provide operational and project engineering support in order to maintain reliable and compliant operation of the manufacturing and packaging equipment within the facility at Hatfield. To ensure that operations carried out within your area of responsibility are conducted in accordance with the requirements of the Quality System, GMP Guidelines and Industry Standards.

Duties are performed to ensure:

• A safe working environment is maintained for self and other employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.
• The quality of products manufactured and released is assured through adherence to all procedures.
• Opportunities to improve operations and reduce cost are identified and progressed through continuous improvement and demand innovation initiatives.
• All stakeholder and customer expectations are understood and met through communication.
• Performance is in line with personal objectives with demonstrated behaviours and competencies.

General responsibilities include:

• Providing engineering technical expertise to support the operations of the site in accordance with Good Manufacturing Practice (GMP) and Good Engineering Practice (GEP).
• Optimisation of Manufacturing and Packaging plant and equipment to ensure reliability and efficiency in terms of cost and availability.
• Delivering improvements to equipment reliability and availability, maintaining metrics and KPI to demonstrate performance.
• Resolving complex problems that do not have routine solutions.
• Providing support to craft and technician grade personnel when technical issues are escalated.

Compliance tasks involve:

• Co-ordinating and participating in the development of risk assessments and method statements associated with specified work.
• Undertaking Change Management, Deviation Investigation, Corrective Action and Preventative Action (CAPA) activities, root cause analysis (RCA) and continuous improvement projects.
• Participating in internal and external audits.
• Generating Standard Operating Procedures for Engineering and related activities.
• Participating in Critical Device/Instrument assessments and development of associated Critical Device lists.

Maintenance responsibilities include:

• Defining 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.
• Defining equipment spares requirements, identifying specifications, sources of supply and stock levels.
• Compiling critical equipment information and hierarchies for input onto the site's controlling maintenance management system.

Project-related duties involve:

• Advising on equipment selection, participating in detailed design development and working with technical services to ensure robust solutions are implemented to ensure reliability.
• Leading or coordinating project planning, resourcing, reporting, commissioning activities for engineering projects.
• Leading commissioning activities to certify equipment will operate in accordance with design intent and to ensure installation and qualification tasks are executed smoothly.
• Supporting Technical services in the qualification and validation of equipment.

Qualifications required:

• HNC/HND/Degree qualified in a relevant engineering discipline (e.g., 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.
• A growth mind-set with a focus on professional self-development.
• Excellent oral and written communication skills.
• Problem solving and root cause analysis.
• Developed attention to detail and with an aptitude for neat, clear documentation.
• Able to work on own and in a multidisciplined team.
• Proven ability to prioritise workload, decisive thinking, and ability to cope with the changing needs of the operation.
• Technology enthusiast.