I am working in partnership with a leading medical device manufacturer, they specialise in the design, development, and manufacture of products for the healthcare industry. They are now looking for a Senior Validation Engineer to join the Team.
The role will involve supporting the site by ensuring the validation of all manufacturing processes and equipment is up to date and drive performance to exceed required operational targets in terms of performance and quality.
• Maintain the organisations Site Master Validation Plan.
• Produce detailed PFMEAs & participate in risk assessment activities in accordance with ISO 14971.
• Produce MVP’s (Master Validation Plans).
• The validation of manufacturing processes and equipment including DOE, IQ, OQ and PQ protocols and reports.
• Be responsible for processing FAT & SAT reports.
• Oversee and/or perform parts critical measurements.
• NPI - Be responsible for all Validation works (including creation of timing plans), to assure on time delivery of projects and transfer into manufacturing, on time and to budget.
• Adhere to good documentation practice and actively contribute to maintaining Technical Files, Design History Files (DHRs) and Device Master Records (DMRs).
• Minimum 5 years’ experience of Process and Product Validation within regulated environments such as Medical, automotive, oil & Gas, Aero space, or Pharmaceutical Industries.
• Strong experience of measurement/inspection activities.
• Experience with GR&R.
• Excellent interpersonal and collaborative skills.
• Experience in with New Product Development would be highly desirable.
• A willingness to get stuck in and be 'hands-on'.