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Process Validation Engineer

Process Engineer / Process Validation Engineer

North West

Initial 6 Month Contract

£Negotiable

We are currently looking for a skilled Process Engineer / Process Validation Engineer for a prestigious Medical Device business based in the North West. The business have a market leading product with a global customer base and are looking to bring someone into their successful engineering team immediately.

Job Summary

You will be supporting the migration of a product that is currently being manufactured by a 3rd party manufacturer in-house and will be responsible for validating both existing a new processes within the plant.

Requirements:

  • Lead an engineering project or provide engineering support to key cross functional projects that support the company's strategy in the Advanced Wound Care department.

  • Take part in the development of business cases to justify projects & feed strong and efficiently created Capital requests (CARs).

  • Working with third party manufacturers for process equipment and dressing design verification and validation.

  • Experience in Medical device industry manufacturing operations.

  • Experience transferring specifications, methods, equipment, processes from R&D to operations at own site and/or third party.

  • Experience working with supporting functions, e.g. Procurement, Supply chain, Quality Assurance, Regulatory Affairs, EHS, etc.

  • Understand the implications & requirements of working to regulations and standards. For example: experience working to quality management system (QMS) standards, e.g. ISO13485, quality system (QS) regulations, e.g. FDA 21CFR 820. Work under MDD 93/42/EEC ((transitioning to MDR (EU) 2017/745)) and/or IVDD 98/79/EC ((transitioning to IVDR (EU) 2017/746)). Understand cGxP principles (FDA & MHRA) and their implementation in various areas, e.g. GAMP 5. Understand and work to regulations and standards relevant to EHS.

  • Experience implementing other standards that support manufacturing, e.g. ISO14644 (Clean Rooms), ISO11462 (Statistical Process Control), etc.

  • Experienced in process validation, setting process specifications and assessing process capability.

  • Experience in implementing and validating equipment, processes and/or facilities (DQ, FAT, SAT, IQ, OQ, PQ, EQ, SQ, PMQ, DVal).

  • Experience preparing User Requirements Specifications (URS) and documentation.

  • Application of risk management tools such as pFMEA.

  • Problem solving skills, e.g. root cause investigation, root cause analysis, implementation and effectiveness of corrective and preventive actions (CAPA).

  • Experience working within a culture of continuous improvement (CI).

  • Fluent PC skills including Word, Excel, PowerPoint, plus ideally MS Project and Minitab.

  • Effective communication skills and able to communicate appropriately at all levels in the organization.

  • Strong oral and written communications skills.

  • Excellent presentation skills.

  • Demonstrated Project Management skills, including a track record of creating plans and meeting deadlines.

  • Proven ability to balance multiple, competing priorities.

  • Ability to lead, influence, create and work within cross-functional team environments.

  • Lean / Six Sigma knowledge

Please note that some travel (approximately 10%) is required. This could involve factory visits to equipment suppliers and third party manufacturers during the design, build and acceptance phases of projects.

Education/Experience/Qualifications Required

  • Degree qualified in an Engineering Discipline or equivalent experience

  • Process engineering & validation experience within the medical device manufacturing sector

  • Experience within both process and packaging validation

  • Member of Professional Body such as IET and working towards CEng status is desirable

  • Six Sigma qualification is desirable