• Full Time
  • Hebburn
  • Salary: £30,000 - 32,000
  • Reference ID: 31/JV/11409

We are working with our client who are a leading plastic products manufacturer in the search for a Validations Engineer.

The primary task of the role is to ensure that all site validation needs are met.

It will be the primary function validate all production, service provision, computer and software based processes, the result of which cannot be verified by subsequent monitoring or measurement. Validation must demonstrate the ability of these processes to consistently achieve expected results.

The role includes re-validation of established processes as well as initial validation of amended or new processes, such as those introduced through new product development activities.

Responsibilities:
– Gain a comprehensive understanding of regulatory requirements applicable to the company
– Collate product information and keep updated for product ranges to enable use in export registration requests
– Ensure technical files are maintained and reviewed regularly against all regulatory standards
– Ensure all licensing information is logged
– Liaise with the Quality department on aspects of quality related documentation where required
– Familiarization with worldwide regulatory bodies and registration requirements
– Ensure naming conventions are consistent throughout all documentation
– Work alongside NPD in the process of incorporating new products into the business, ensuring all relevant documentation is available and stored in the correct areas for easy access

Person Specification:
– Mechanical or Electrical Degree
– A background in medical or pharmaceutical would be advantageous
– Previous experience in manufacturing and quality assurance
– Good organisation skills and methodical approach to work
– Excellent communication skills
– Self-Reliance with the ability to work with the minimum of supervision, on his/her own initiative

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