Engineer I, QA Validation

at  Thermo Fisher Scientific

POSITION SUMMARY:

As an Engineer I, you will coordinate the completion of validation projects in order to implement manufacturing improvements and confirm the validation status of existing processes/equipment. Working with teams across development and production, you will lead project related validation activities to drive the progression of validation/qualification documents to meet quality system regulations. All aspects of validation (Process, Analytical Method, Cleaning, Software, and Equipment) are covered, providing a range of opportunities with which to apply your scientific/validation/engineering knowledge.

PREFERRED SKILLS/EXPERIENCE:

We encourage candidates that enjoy working in a multi-disciplinary, highly technical environment where personal development and team collaboration are keys to success. Knowledge of validation/GMP will be of benefit, however, training will be provided and a desire to learn and be educated in the principles of validation is expected. Excellent attention to detail is a must, as is the ability to individually manage priorities appropriately. Reviewing and interpreting scientific data/methods is desirable as it will allow you to build strong relationships with internal customers.

• Qualifications: Minimum - A-Levels or equivalent in Science. A Bachelors degree in Life Sciences is preferred.
• Meaningful experience of a manufacturing environment (IVD or medical device industry is desirable).
• Knowledge of ISO 13485 and FDA Part 820.
• Excellent IT skills. Proficiency in Excel is desirable.

Apply today! http://jobs.thermofisher.co

• Assisting senior QA Validation team members to define a suitable validation strategy.
• Preparing and delivering documentation for validation projects (requirements/protocols/reports).
• Confirming that validation is carried out to schedule and aligns with company procedures/templates.
• Ensuring issues raised during protocol execution are identified, reported in a timely fashion, and captured in a deviation report.
• Carrying out validation trials and documentation of results.
• Reviewing completed protocols in accordance with the company data integrity policy.
• Contribute to updates of validation procedures led by senior colleagues.
• Perform validation periodic reviews and liaise with SMEs for necessary updates.