Engineer II, QA

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

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 vital 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.

Quality Validation Engineers provide support of the QA Validation functions for Operations at the Cambridge location (250 Binney Street).

A day in the Life:

• Approve system life cycle work 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/PV and CQV work 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 AMV/AIV/PV and CQV, ensuring validation impact assessment, procedural impact, regulatory impact, and prescribed testing are adequate and well justified.
• Support the maintenance, calibration, and periodic review of equipment/instruments and systems.
• Provide Quality review and approval of qualification and validation protocols and reports, including gap analysis, associated change controls and testing procedures.
• Drive continuous GMP improvement in the AMV/AIV/PV and CQV.
• Represent QA on all assigned projects in support of AMV/AIV/PV and CQV activities.
• Provide support in other quality system related activities including quality deviations/discrepancies and change controls.

Keys to Success:

Education

• BA/BS minimum in Life Sciences
• 5+ years for BS or 2+ years for MS, in a Quality role.

Experience

• Experienced in process equipment and analytical instrument IOQ and PQ.
• In-depth experienced in biotech / pharmaceutical.
• Experience in molecular biology/cell biology is a plus.
• Experience supporting health authority inspections is a plus.
• Equivalent combinations of education, training, and meaningful work experience may be considered.

Knowledge, Skills, Abilities

• Proven understanding of qualification and validation methodologies.
• Proven understanding 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.
• Solid understanding of GxP mentorship, including 21 CFR Part 11, Annex 11, Data Integrity, ICH Q7, Q8, Q9, Q10, USP , USP , USP and other international regulatory requirements.
• Strong interpersonal skills, both verbal and written.
• Solid understanding 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 multifaceted, fast-paced environment with a clear sense of urgency.
• Excellent organizational skills and attention to detail and accuracy.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific). A one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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 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.