Thermo Fisher Scientific

Quality Engineer III

Thermo Fisher Scientific • $85K — $100K *
Saint Louis, MO 63129In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical discipline.
  • 3+ years of experience with an advanced degree or 5+ years with a bachelor's degree in quality assurance within a regulated environment.
  • Experience in supporting GMP quality systems and ensuring regulatory compliance.
  • Familiarity with biologics manufacturing or biopharmaceutical processes is preferred.
  • ASQ certifications such as CQE or CQA are advantageous.

Responsibilities

  • Support quality assurance activities for clinical and commercial manufacturing programs.
  • Partner with cross-functional teams to ensure compliance with GMP and regulatory requirements.
  • Review and approve GMP documentation like batch records and CAPAs.
  • Lead investigations into quality events and implement corrective actions.
  • Analyze quality metrics to identify trends and recommend improvements.
  • Participate in quality planning and risk assessments for product lifecycle management.
  • Support technology transfer activities for new manufacturing processes.

Benefits

  • Competitive remuneration package with annual incentive bonuses.
  • Comprehensive healthcare benefits and a variety of employee perks.
  • Opportunities for career advancement in an innovative company culture.
  • A work environment that emphasizes integrity, intensity, involvement, and innovation.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

As a Quality Engineer III within the Product Quality organization, you will play a key role in supporting quality assurance activities for clinical and commercial manufacturing programs. In this individual contributor role, you will partner with cross-functional teams to ensure products are manufactured in compliance with applicable regulatory requirements while supporting operational excellence and continuous improvement initiatives.

You will apply your technical expertise to investigate quality events, support quality systems, identify process improvements, and help ensure products consistently meet customer and regulatory expectations. Your contributions will directly support Thermo Fisher Scientific's commitment to delivering high-quality products and enabling customer success.

Key Responsibilities
  • Support quality assurance activities for clinical and commercial manufacturing programs.
  • Partner with Manufacturing, Operations, Engineering, Validation, Regulatory Affairs, and other functional teams to ensure compliance with GMP and regulatory requirements.
  • Review and approve GMP documentation, including batch records, deviations, change controls, CAPAs, and validation documentation.
  • Lead quality investigations, perform root cause analyses, and support the implementation of effective corrective and preventive actions.
  • Evaluate quality system data and metrics to identify trends and recommend process improvements.
  • Participate in risk assessments and quality planning activities to support product lifecycle management.
  • Support technology transfer activities and implementation of new manufacturing processes.
  • Participate in internal audits, customer audits, and regulatory inspections.
  • Contribute to continuous improvement initiatives that strengthen quality systems and operational performance.
  • Maintain current training requirements and ensure compliance with company policies, GMP regulations, and applicable quality standards.
  • Perform other duties as assigned.

Minimum Qualifications

Education
  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or another scientific or technical discipline.

Experience
  • Advanced degree with 3+ years of experience, or bachelor's degree with 5+ years of experience in quality assurance within a regulated pharmaceutical, biotechnology, medical device, or related manufacturing environment.
  • Demonstrated experience supporting GMP quality systems and regulatory compliance.

Preferred Qualifications
  • ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant quality certification.
  • Experience supporting biologics manufacturing or biopharmaceutical processes.
  • Experience with technology transfer and process validation.
  • Experience supporting customer audits and regulatory inspections.
  • Experience applying statistical analysis and quality metrics to drive continuous improvement.

Knowledge, Skills, and Abilities
  • Working knowledge of FDA, EMA, ICH, GMP, and applicable regulatory requirements.
  • Experience with deviation investigations, CAPA management, change control, quality risk management, and document control.
  • Knowledge of validation and qualification activities.
  • Strong analytical and root cause problem-solving skills.
  • Effective project management and organizational skills.
  • Excellent written and verbal communication skills.
  • Ability to collaborate effectively across multiple functional teams.
  • Ability to prioritize multiple assignments in a fast-paced environment.
  • Proficiency with Microsoft Office applications and quality management systems.
  • Strong attention to detail and commitment to quality.

Competencies

Successful candidates will demonstrate:
  • Customer focus
  • Collaboration and teamwork
  • Quality and compliance mindset
  • Accountability and ownership
  • Continuous improvement orientation
  • Technical problem solving
  • Effective communication
  • Sound judgment

Work Environment

This position operates in a regulated GMP manufacturing environment and may require interaction with production, laboratory, warehouse, and office-based functions. Occasional travel (up to 25%) may be required.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Other

Relocation assistance is not provided.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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