Terumo Aortic require an experienced and skilled validation engineer to join their growing engineering function in Inchinnan, Renfrewshire.
MAIN PURPOSE OF JOB AND OBJECTIVES
Primarily accountable for the validation and validation maintenance of manufacturing processes, and test methods, manufacturing equipment and facilities.
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
- Execute to completion IQ, OQ and PQ of Manufacturing Equipment and Processes to meet regulatory requirements
- Prepare and issue Validation Master Plans and schedules, summary reports and other required documentation for a validation exercise
- Organize and execute validation activities in order 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 and when required
- Provide specialist knowledge on process, 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
- 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
- Perform any other duties/tasks/projects as require by management
- Assume other responsibilities from time-to-time in order to support plant’s strategic plan and personal career plans
- Responsible for archiving and storage of all completed and approved validation documents
The successful candidate will possess;
- Degree qualified with validation experience from within a scientific regulated environment
- A good working knowledge of appropriate standards and regulations
- Experience in direct investigation/troubleshooting of validation problems
- Experience in executing IQ/OQ/PQ and Test Method Validations
- 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 re-qualification
- 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