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Process Engineer - Manufacturing / Packaging Lines, Hatfield
Client: Cpl Life Sciences
Location: Hatfield, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Views: 6
Posted: 18.04.2025
Expiry Date: 02.06.2025
Job Description:
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 costs are identified and progressed through 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 organizational objectives with demonstrated behaviours and competencies.
Responsibilities:
General:
* Provide 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.
* 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 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.
* Lead or coordinate project planning, resourcing, reporting, and commissioning activities for engineering projects.
* Lead commissioning activities to certify equipment will operate in accordance with design intent and ensure installation and qualification tasks are executed smoothly.
* Support Technical services in the qualification and validation of equipment.
Qualifications:
* 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).
* Professional membership - IMechE, IET, PMI, APM, ISPE (or similar).
* Practical experience of GMP manufacturing, packaging processes & equipment within MHRA / FDA regulated facilities.
* Demonstrable awareness of commissioning, qualification, and validation project activities.
* Comfortable with technology.
* A growth mindset with a focus on professional self-development.
* Excellent oral and written communication skills.
* Problem solving and root cause analysis.
* Developed attention to detail with an aptitude for neat, clear documentation.
* Able to work independently and in a multidisciplinary team.
* Proven ability to prioritise workload, decisive thinking, and ability to cope with the changing needs of the operation.
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