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
Essential Experience/Qualifications
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
Desirable Experience/Qualifications
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
Hours of Work
40 hours per week
Monday to Friday
Equal Opportunities
We are committed to creating a diverse and inclusive workplace for all. We are an Equal Opportunities Employer and welcome applications from all individuals, regardless of age; disability; gender; gender reassignment; marital or civil partnership status; pregnancy and maternity; race; religion or belief; sexual orientation, or any other characteristic protected by law. We believe that diversity enriches our workplace and enhances our ability to deliver exceptional results. We assess all applications based on skills, qualifications, and experience, ensuring a fair and equitable recruitment process.
**No Agencies please