Lead Quality Validation Engineer

Employer
Thermo Fisher Scientific
Location
Cambridge, MA
Posted
Jul 20, 2021
Closes
Jul 22, 2021
Ref
2329742010
Organization Type
Corporate
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.
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 cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
*Location:*
Cambridge, MA
*How will you make an impact?*
Quality Validation Engineers provide senior level support of the QA Validation functions for Operations.
*What will you do? *
• Primary Duties of this position is to provide senior level support of the QA Validation functions for the Brammer Bio Operations with focus at the Cambridge location. Provide quality oversight of facility/utility and equipment for qualification activities. Review of all documents such as URS, DQ, SAT, FAT, design documents, Qualification protocols (IQ, OQ &PPQ) generated for the qualification and validation of equipment and systems. Carries out duties in compliance with all local, state, and federal regulations and guidelines including the FDA, EU. Complies with all client site policies and procedures.
• Provide technical support on change controls, assessing new change controls for process equipment, utilities and automation systems that are proposed and all the requirements necessary to maintain a validated status. Support sterilization validation efforts. Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary and final reports.
• Support review and approval of generation of quality assurance policies and procedures
• Support interpret and implement quality assurance standards
• Subject matter Expert responsible for maintaining change control system. Provide QAV support and assessments on change controls. Review for execution approval of change controls per change control SOP and client agreement.
• Assure ongoing compliance with quality and industry regulatory requirements
• Review equipment and automation qualification and validation protocols
• Participate in client audits and regulatory inspections by escorting auditors and securing requested documents and data
*How will you get here?
Education*
• Bachelor's Degree in Sciences/Engineering or related field - required.
*Experience*
• Minimum 8 years of industry related experience and direct GMP experience.
• Quality inspection, auditing and testing experience.
• Experience with implementation of corrective action programs.
*Knowledge, Skills, Abilities*
• Must have strong knowledge of 21 CFR, ICH Q9 & ICH Q10, and EU regulations, GAMP, ASTM-E2500.
• Must have strong understanding of QBD, risk Based, and performing Quality Risk Assessments
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
• Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (PROCESS, SAFETY, PERSONNEL) AREA MANAGEMENT.
• Must be able to understand operational documents for GMP compliance, accuracy and completeness

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.

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