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Thermo Fisher Scientific Quality Assurance Validation Engineer in Bedford, Massachusetts

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

The BioProduction Division is one of the fastest growing businesses in the company, supporting developers and manufacturers of biological-based therapeutics and vaccines. ​With our portfolio of best-in-class products that span the bioprocessing workflow from discovery through large-scale commercial production, our business is driving performance in bioprocessing through collaboration with our customers .

How will you make an impact?

Within the Quality organization of the Bedford, MA facility, we are seeking a Quality Assurance Validation Engineer for an exciting opportunity for an experienced This position will interface and closely work with other cross-functional team members such as Facilities, Engineering, Operations and QC.

You'll be a proven team member with experience in working with high-performance teams, bringing a strong compliance understanding, technical expertise and project management skills to enhance our Quality Team.

What will you do?

Supporting the Quality Organization, the Quality Assurance Validation Engineer will:

  • Quality Assurance Validation Engineer will be responsible for supporting validation activities related to Facilities, Utilities, Engineering, Quality Control and Operational equipment.

  • Provide quality oversight of facility and equipment commissioning, Factory Acceptance Test (FAT) and other activities.

  • Review and approval equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols (pre execution) and reports (post execution).

  • Review and approve any validation related deviations and discrepancies.

  • Review and approve any Process Validation (PV), Cleaning Validation and Computer System related protocols (pre execution) and reports (post execution).

  • Provide QA support for risk assessment and FMEA.

  • Coordinate validation activities with cross-functional team members to make validation activities efficient and complaint with the regulations.

  • Provide quality oversight on Facility shutdown and startup plans.

  • Provide oversight on Validation Lifecycle Management program.

  • Adhere to in-house processes and procedures maintaining compliance to ISO 13485 standards.

  • Maintain and support a safety and quality culture.

How will you get here?

Education and Experience

  • Bachelor's or equivalent degree from accredited college/university in Engineering/relevant scientific discipline and have a strong project management and technical background. Preferred advanced degree i.e., Masters or Doctorate.

  • Minimum 3 years of relevant Validation experience.

  • Experienced in Quality oversight of validation activities.

  • Experience with internal and customer audits.

Knowledge, Skills, Abilities

  • Knowledge of Quality standard (e.g., ISO 13485), FDA, ICH (International Council for Harmonization) Quality guidelines.

  • Good understanding of ISO 13485 requirements including CAPA, Risk Assessments, FMEA, Deviation investigation and Change Control process.

  • Document review experience such as, but not limited to, equipment qualification, process and cleaning validation, Computer system, analytical method validation.

  • Good understanding of project management skills.

  • Familiarity with SAP, Trackwise, Agile, E1, LIMS systems

  • Ability to work independently or as part of a team.

  • Flexibility to adapt to a dynamic environment and manage activities to meet the needs of the business while maintaining a focus on quality.

  • Versed in continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others.

  • Excellent inter-personal, communication and organizational skills with good attention to detail.

  • Ability to produce and present original quality communication materials for internal and external audiences.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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