Job Title: Engineer III, QA Analytical Instrument/Method Validation

Requisition ID: 118100BR

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

This position will report into the Viral Vector Services (VVS) group at Thermo Fisher Scientific and will be based in the Cambridge, MA office.

How will you make an impact?

The Specialist III, Analytical Instrument Validation (AIV)/ Analytical Method Validation (AMV) will be responsible for providing Quality support to the life cycle of analytical equipment/instrumentation and analytical method validation / verification, including qualification and validation activities, the change-control aspects of validation, instrument maintenance, instrument calibration, and periodic review activities. This individual will support AMV activities and drive continuous GMP improvements in the AMV lifecycle ensuring that all testing is performed according to the GxP regulatory requirements. Additionally, the individual will focus on ensuring consistent policy administration, implement key improvement initiatives and solve compliance issues in partnership with business owners.

What will you do?

• Approve system life cycle deliverables and activities to ensure that procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported to support lifecycle activities.
• Provide Quality review and approval of AIV/AMV deliverables including validation plans, user requirement specifications, risk assessments, protocols, test scripts/reports, and associated deviations to assure compliance with company standards, practices, and industry requirements.
• Provide support of the change-control aspects of AIV/AMV, ensuring validation impact assessment, procedural impact, regulatory impact, and prescribed testing are adequate and well justified.
• Support the instruments maintenance, calibration, and periodic review.
• Provide Quality review and approval of analytical methods, method validation protocols and reports, including associated change controls and testing procedures.
• Drive continuous GMP improvement in the AIV and AMV.
• Report and trend performance metrics for AIV/AMV projects
• Represent QA on all assigned projects in support of AIV and AMV activities
• Conduct internal electronic data integrity audits for Computerized Systems for GxP Operations.
• Support client audits and regulatory inspections by representing the company as a subject matter expert.
• Provide support in other quality system related activities including quality exceptions and change control.

How will you get here?

Education

• BA/BS required in Life Sciences

Experience

• 6 or more years working in a Quality role desired
• Experience in analytical method validation, transfer and lifecycle management
• Life Sciences biotech / pharmaceutical experience desired
• Experience supporting health authority inspections a plus.

Knowledge, Skills, Abilities

• Working knowledge of analytical instrument qualification and validation methodologies
• Working knowledge of IT Controls methodologies, including GAMP5, the computerized system development life cycle, and software quality assurance in a regulated environment
• Working knowledge of analytical and compendial method validation and verification methodologies
• Solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11, Data Integrity, ICH Q7, Q8, Q9, Q10, USP <1058>, USP <1225>, USP <1226> and other international regulatory requirements.
• Strong communication skills, both verbal and written
• Ability to work both independently and with teams at various levels in the organization
• Ability to work in a very dynamic environment with a clear sense of urgency
• Excellent organizational skills and attention to detail and accuracy

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.