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

Intersurgical; Wokingham; In loco; GBP 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

Intersurgical UK is seeking an experienced Process Engineer to develop, optimise and validate manufacturing processes within the Site Engineering Department. You will coordinate IQ, OQ and PQ activities and support continuous improvement across production and quality practices.

You will apply medical device quality requirements (ISO 13485) and work with cross‑functional teams to resolve process issues, document protocols, and drive compliant, efficient manufacturing.

Competenze

• Experience in process validation and qualification incl. IQ/OQ/PQ.
• Experience in process optimisation and continuous improvement.
• Knowledge of ISO 13485 and medical device quality requirements.

Mansioni

• Develop, optimise and improve manufacturing processes.
• Plan and execute IQ/OQ and PQ activities.
• Support validation and qualification projects to ensure compliance.
• Collaborate with cross‑functional teams to resolve process issues.

Conoscenze

IQ/OQ/PQ

Process validation

Process optimisation

Documentation

Quality systems

Formazione

Engineering degree

Strumenti

Microsoft Office

Quality Management Systems

Descrizione del lavoro

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