Deviation Investigator

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

When you're 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. Working for Thermo Fisher Scientific provides a unique opportunity to make a meaningful impact in the world. Employees contribute to groundbreaking advancements in science and healthcare, helping to develop innovative solutions that improve lives globally. Thermo Fisher offers a collaborative and dynamic work environment where your skills and expertise can drive significant progress in fields like biotechnology, pharmaceuticals, and diagnostics. By joining Thermo Fisher, you become part of a mission-driven organization dedicated to enabling customers to make the world healthier, cleaner, and safer. Your work will not only advance your career but also make a lasting difference in the lives of millions. Your work will have real-world impact!

Location/Division Specific Information

Thermo Fisher Scientific's facility in St. Louis, MO, offers comprehensive services for developing and manufacturing biologic drugs. The 96,875-square-foot facility supports the entire process, from initial development to commercial production. It has extensive cell culture capabilities and can handle batch sizes from 100 grams to 20 kilograms using advanced single-use equipment.

The site is a leader in single-use technology, providing flexible options for scaling up production from 50 liters to 5,000 liters. The new 5,000-liter Dynadrive bioreactor, developed at the facility, showcases Thermo Fisher's expertise in biologics manufacturing and bioprocessing.

How will you make an impact?

We are seeking a Deviation Investigator to analyze and investigate deviations or non-conformances, using problem-solving tools like root cause analysis. This role involves collecting relevant data, analyzing it to identify patterns or potential causes, and documenting findings comprehensively. You will collaborate with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs). Timely written documentation of investigations and communication of recommendations based on outcomes are essential.

What will you do?

• Manage deviation investigations, including assembling investigation teams, leading root cause analysis, and development of CAPAs.
• Document findings in a comprehensive, compliant, and objective manner, ensuring accurate recording of all relevant information.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, process engineering, and regulatory affairs, to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).
• Ensure timely completion of investigations.
• Clearly communicate investigation progress to impacted areas and leadership.
• Participate in client communications and responses, working closely with program team leads, quality, and management.
• Continuously improve investigation processes and tools to enhance efficiency and effectiveness.
• Escalates issues timely and appropriately.

How will you get here?

Education

• BS/BA in biology, biochemistry, chemistry, chemical engineering, or other science-related field preferred
• HS Diploma

Experience

• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility preferred
• 5+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success preferred
• 3+ years of experience working in biologics preferred.
• Experience using a Quality Management System such as Veeva or Trackwise.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, ISO) and Good Manufacturing Practices (GMP).

Knowledge, Skills, Abilities

• Strong written and verbal communication skills.
• Ability to evaluate data and make recommendations based on trends and trend analysis.
• Ability to work effectively in a fast-paced environment and prioritize tasks.
• Ability to facilitate meetings for desired outcomes.
• Proven experience with root cause analysis and CAPA processes.
• Excellent analytical and problem-solving skills.
• Ability to work independently and manage multiple investigations simultaneously.

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.

Must be legally authorized to work in the United States now and in the future, without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.