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Quality Engineer, AMV/AIV

Company: Thermo Fisher Scientific
Location: Cambridge
Posted on: November 22, 2021

Job Description:

When you are 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. At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading, and groundbreaking, Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. *How will you make an impact?* The Quality Engineer, Analytical Method Validation (AMV) /Analytical Instrument Validation (AIV) individual will play a key role in providing Quality support to the life cycle of AMV/verification and analytical equipment/instrumentation. *Location:* * Cambridge, MA *What will you do? * * Approve system life cycle output 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 AMV/AIV projects 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. * Support the change-control aspects of AMV/AIV, ensuring validation impact assessment, procedural impact, regulatory impact, and prescribed testing are adequate and well justified. * Support the analytical instruments' maintenance, calibration, and periodic review. * Supply Quality review and approval of analytical method transfer, qualification and validation protocols and reports, such as gap analysis, associated change controls and testing procedures. * Drive continuous GMP improvement in the AMV/AIV. * Report and trend performance metrics for AMV/AIV projects. * Represent QA on all assigned projects related to AMV/AIV activities. * Conduct internal electronic data integrity audits for Computerized Systems for GxP Operations. * Participate in client audits and regulatory inspections by representing the company as an SME. * Assist in other quality system related activities including quality deviations/discrepancies and change control. *How will you get here?* *Education/Experience* * Bachelor's Degree in Life Sciences required with 6+ years' experience in a Quality role * Equivalent combinations of education, training, and relevant work experience may be considered. *Experience* * Highly qualified in analytical method transfer, qualification, validation, and lifecycle management. * Experienced in analytical instruments IOQ and PQ. * In-depth experience in biotech / pharmaceutical or related industry * Extensive experience in molecular biology/cell biology preferred * Experience supporting health authority inspections a plus. *Knowledge, Skills, Abilities* * 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. * Knowledge of analytical and compendial method validation and verification methodologies. * Proven understanding of GxP guidance, including 21 CFR Part 11, Annex 11, Data Integrity, ICH Q7, Q8, Q9, Q10, USP , USP , USP and other international regulatory requirements. * Strong communication skills, both verbal and written. * Strong knowledge Microsoft Suite (word, excel and power point) and TrackWise. * Ability to work both independently and with teams at different levels in the organization. * Ability to work in a very dynamic, fast-paced environment * Excellent organizational skills and attention to detail and accuracy. At Thermo Fisher Scientific, each one of our 90,000 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.

Keywords: Thermo Fisher Scientific, Cambridge , Quality Engineer, AMV/AIV, Engineering , Cambridge, Massachusetts

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