Terumo Aortic are currently recruiting for an Engineering Leader – Validation to join our team. This is an exciting role where your primarily accountable for the validation and validation maintenance of manufacturing processes, and test methods, manufacturing equipment and facilities. Whilst working alongside a great team this is an excellent opportunity for someone to truly make a difference.

The main responsibilities of the role are;

• Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives
• Perform validation of processes, equipment and facilities used in manufacture of medical devices to meet Regulatory requirements, this incorporates completion of validation protocol, installation qualification, operational qualification and performance qualification and supporting documentation
• Prepare and issue Validation Master Plans and schedules, summary reports and other required documentation for a validation exercise
• Organize and execute validation activities to provide an effective validation service
• Provide validation expertise to ensure that all operations are carried out in compliance with regulatory and company requirements
• Provide validation support and advice to other areas of the business as required
• Ensure projects relating to processes, facilities and equipment, are validated in line with regulatory and company requirements
• Provide specialist knowledge on process, facility, equipment issues within the site
• Promote effective working relationships and ensure they are maintained through the validation working party
• Support a continuous improvement culture within the business
• Provide guidance, and direction to staff consistent with ISO13485 and 21 CFR 820
• Develop work plans, assign tasks, and supervise teams as appropriate
• Ensure staff have appropriate knowledge and training on department and site, processes and procedures
• Address site validation gaps via generation and completion of Validation Master Plans and schedules
• Maintain site validation status according to regulatory requirements
• Identify resource requirements and rate limiting steps within Validation Master Plan compliance
• Support the provisions of quality data/reports/charts for the manufacturing group
• Generate relevant required documentation in support of regulatory updates and filings
• Supervise assigned Validation engineers within the Manufacturing engineering team, to ensure individual allocated tasks are met within agreed timescales, allocating tasks to team members as appropriate

The successful candidate will possess;

• Degree qualified
• Validation experience from within a scientific regulated environment
• A good working knowledge of relevant standards
• Experience in direct investigation/troubleshooting of validation problems
• Experience in Analytical Test Method Validation
• Experience in Equipment Qualification Good statistical knowledge (DOE, capability studies, Gauge R&R, sample size definition, etc)
• Experience in the areas of qualification, analytical methods, lab equipment qualification, computer system validation, and requalification
• Proficiency in Minitab and Microsoft packages will be a requirement
• A natural influencer who is energetic in the pursuit of improved processes and innovative in developing solutions