Engineer I, QA Validation

Work Schedule

Environmental Conditions

Job Description

About the job

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 75,000 employees globally. As part of the team, we will do important work, like helping our customers accelerate life sciences research, solve complex analytical challenges, and improve patient diagnostics. All whilst being supported in achieving your career goals.

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.

Key Responsibilities:

• Assisting senior QA Validation team members to define a suitable validation strategy.

• Preparinganddeliveringdocumentationfor validationprojects (requirements/protocols/reports).

• Confirming thatvalidation iscarriedouttoschedule and aligns with company procedures/templates.

• Ensuring issues raised during protocol execution are identified, reportedinatimelyfashion, and captured in a deviation report.

• Carrying out validation trials and documentation ofresults.

• 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.

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.com