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 Corporate Standards, Quality System, GMP and GDP Guidelines and Industry Standards.
The Quality of products manufactured and released is assured through adherence to all procedures.
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
EIT / Manufacturing business systems
Compliance, business effectiveness and legal departments
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.
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.
Generate Standard Operating Procedures for Engineering and related activities.
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.
Compile critical equipment information and hierarchies for input onto the site's controlling maintenance management system.
Projects
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.
HNC/HND/Degree qualified in a relevant engineering discipline (e.g., chemical, electrical, mechanical engineering)
Project Management training – CAPM / PMQ (or equivalent).
Understanding / training in Lean Six Sigma
Practical experience of GMP manufacturing, packaging processes &/or equipment within MHRA / FDA regulated facilities.
Demonstrable awareness of commissioning, qualification, and validation project activities.
A growth mind-set with a focus on professional self-development.
Problem solving and root cause analysis.