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 carried out in accordance with the requirements of the Quality System, GMP Guidelines and Industry Standards.
To ensure that operations conducted are performed in accordance with the requirements of Eisai Corporate Standards, Quality System, GMP and GDP 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 the continuous improvement and demand innovation initiatives.
- Eisai’s philosophy of hhc is at the forefront of daily activities.
- All stakeholder and customer expectations are understood and met through communication.
- Performance is in line with personal and objectives with demonstrated behaviours and competencies.
- Production Engineering, Utilities Engineering, and Facilities Management Engineering
- Production Operations
- Project Key Sponsors, Stakeholders, and Project teams
- Quality Operations, Quality Control and Quality Systems
- Environmental, Health and Safety (EHS)
- Technical
- EIT / Manufacturing business systems
- Compliance, business effectiveness and legal departments
General
- 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 plant and 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.
- Resolve 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.
- 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.