Engineer Iii, Qa

JOB DESCRIPTION

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

EDUCATION

• Bachelor’s Degree in biology, biochemistry, chemistry or other science related field preferred or equivalent experience in lieu of education requirements.
• Non-science degrees will be considered with appropriate confirmed experience.

EXPERIENCE

• 5+ years of experience within a GMP Environment.
• 4+ years of experience within a professional level Quality Assurance, Quality Operations, or Compliance preferred.
• Ability to apply GMP/GLP regulations and other international guidelines to all aspects of the position.
• Proficient knowledge of controlled documentation and data systems.

KNOWLEDGE AND SKILLS

• Knowledge of industry standards and cGMP regulations.
• Preferred knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP/GLP regulations and other international guidelines to all aspects of the position.
• Proficient knowledge of controlled documentation and data systems.
• Decision Making and Leadership Skills
• Technical knowledge of biopharmaceutical manufacturing is desirable.
• Proven ability to make key and timely decisions.
• Proven ability to influence others and lead significant change. Able to work collaboratively with various departments in the organization and clients to identify and implement solutions to address quality/compliance issues.
• Excellent organizational skills and problem-solving abilities.
• Able to aseptically gown and work in environmental clean rooms, as needed.

ABILITIES

• Able to aseptically gown and work in environmental clean rooms, as needed.
• Able to complete job functions under minimum guidance or oversight from other Quality Engineers or manager.
• Ability to work 8-hour fixed schedule onsite with possible weekend work or on call coverage.
• Physical: Regularly required to talk and hear. The employee may be required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
  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. As 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.

Coordinates and ensures the successful day-to-day oversite of contract manufactured biologic molecule(s).

• Provide quality minded problem resolution to on the floor manufacturing activities and any escalations stemming from production, other QA Engineers, and Quality On the Floor. Monitor and coordinates resolutions of issues.
• Provide guidance, review, and approval of GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures/Controlled Documents, Technical Transfer Protocols, Deviations, CAPAs, Change Controls, and other Quality Records.
• Assisting Product Quality Leads during technology transfer of new products; ensuring development of process adheres to applicable regulations based on phase appropriate FDA, EMA and ICH guidelines. Oversight to include work from Process Development to Process Validation.
• Perform routine quality walk throughs of assigned production and production support areas.
• Participate in site inspection readiness activities and site inspections.
• Drive continual process improvement by participating in meetings, seminars, and site projects.
• Participate as needed in client activities such as client audits, client face to face meetings, and client core team meetings.
• Responsible for completing training tasks based upon a monitored curriculum.