Process Engineer - Fixed-term contract (2 years and 6 months)

We are looking to recruit an experienced Process Engineer who will be responsible for the development, optimisation, control, qualification, and validation (where necessary) of manufacturing processes. The successful candidate will also coordinate training for the Manufacturing Department and support the continuous improvement of production processes and related quality practices within UK Manufacturing. This position will be based within the Site Engineering Department at our Intersurgical UK medical device manufacturing facility. The successful candidate will be able to:

• Support the development, optimisation, and improvement of manufacturing processes
• Plan and execute process qualification and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Contribute to validation and qualification projects to ensure manufacturing processes meet the required quality standards
• Apply knowledge of medical device regulations and requirements to support compliant manufacturing operations
• Identify opportunities for continuous improvement in production processes and quality practices
• Work collaboratively with cross-functional teams to resolve process-related issues and achieve project objectives
  
  Experience in process validation and qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Experience in process optimisation and continuous improvement
• Ability to contribute to and support validation and qualification projects, A relevant qualification or degree in Engineering, Manufacturing, or a related discipline
• Experience in Medical device manufacturing
• Knowledge and understanding of relevant quality management systems, such as ISO 13485
• Experience in preparing and reviewing technical documentation, including validation/qualification protocols, reports, and standard operating procedures (SOPs)
Key Skills
• Able to effectively manage validation and qualification projects
• Excellent verbal and written communication skills
• Able to build good working relationships
• Able to work well under pressure and meet deadlines
• Able to multitask and prioritise workload
• Able to make decisions
• Able to work independently as well as within a team
• Able to work effectively across a number of interrelated departments
• Self-motivated
• Keen and willing to learn
• Have a can-do attitude with an enthusiastic approach to work
• I.T. Literate - Microsoft Office
• Methodical, organised and structured approach to work
• Excellent attention to detail
• Able to gather, evaluate, critically interpret and communicate information
• Strong analytical and problem solving skills
• Able to work in a safe manner complying with Health and Safety Legislation
• Able to function in a highly regulatory environment with a focus on compliance
• Able to act in a fair and reasonable way
• High level of commitment
• Flexibility to work additional hours if required to support the business needs
• Good levels of English speaking
• Physically fit and able to perform tasks of a manual nature