North West England, England
2 months ago
Job page.job details.consultant:
Process Engineer / Process Validation Engineer
Initial 6 Month Contract
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.
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.
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.
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