Process Validation Engineer/Moulding Specialist

Location: Cheltenham  |  Gloucestershire  |  England
Sector: Life Sciences
Consultant: Harvey Havell
Job Reference: HQ661/SMHH
Salary: £40000 - £45000
Job Status: Permanent / Full Time

JOB TITLE: Validation Engineer / Moulding Specialist

SALARY: £45k+ depending on experience

LOCATION: Outskirts of Cheltenham

DEPARTMENT: Engineering

REPORTING TO: Engineering Manager

STARTING: ASAP

 

KEY PURPOSE OF ROLE:

  • Responsible for completing validation & technical activities in support of routine manufacturing production, introduction of new products into manufacture and development of the existing products & processes. Particular focus on working with injection moulded components to support existing products and NPI. 

RESPONSIBILITIES OF THE ROLE:

  • Reporting to the Engineering Manager, taking a lead role in industrialization phase of New Product Introduction projects.
  • Responsible for providing DFM/DFA guidance to Design department.
  • Point of contact for suppliers to ensure products and processes supplied to the company are specified and manufactured correctly.
  • Responsible for ensuring all products, equipment and processes either supplied to the company, or conducted on site, are adequately verified/validated.
  • Able to take ownership of existing mould tooling, supporting suppliers on maintenance and repair schedules. Identifying opportunities to reduce breakdowns and improve utilization.
  • Provide subject matter expertise for Process Validation of Injection mouldings and associated assembly methods.
  • Able to generate all required documentation to complete a Process Validation in accordance with current Medical Device regulations.
  • Prepare detailed project plans using MS Project to include all tasks required to deliver the NPI phase of NPD.
  • Using metrology skills (inc CMM/VMM) and statistical data analysis (using Minitab) to support both process validation and routine manufacturing investigations.

General duties:

  • Ensuring NPI documentation is correctly reported and filed into Design History Files, Device Master Records and Summary Technical Documentation (STED) as appropriate.
  • Able to deputise for the Engineering Manager when required.
  • Manage revalidation, process FMEA and other Engineering duties in line with the change process.
  • Assist with production problem solving or subsequent resolution.

 

QUALIFICATIONS AND EXPERIENCE:

  • 5 years of experience in an engineering role within a regulated environment.
  • Experience and exposure to plastics processing and tooling.
  • Desirable to be experienced in shop floor moulding problem solving with 3rd parties using tools such as 8D
  • Experience with process development and validation.
  • A time served engineer or degree qualified within a relevant technical discipline.
  • Excellent communication and interpersonal skills.
  • Experience working within an ISO 13485 (medical devices) environment is beneficial.
  • Desirable, Six Sigma process development

For more information, please get in touch with Harvey @ Seven Life Sciences