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. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

The candidate will be responsible for the performance of tasks in support of the manufacture of Commercial and Clinical Biologics. They will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to the environmental monitoring to ensure an accurate depiction of control for multiple production areas. These functions may include but are not limited to activities such as viable microbial sampling, microbial surface sampling, non-viable (particle) sampling, collecting samples from the on-site water system and gas system.

What will you do?

• Assist in all Department functions, such as routine environmental monitoring, supplies, equipment, logbooks and data in accordance with site SOPs and policies.
• Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.
• Interpret data results in accordance to concepts of microbiology, industry standards, and site SOPs and policies.
• Critical evaluation of processes, including foresight and thinking ahead.
• Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.
• Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.
• Identify deviations and aid in investigations/root cause analysis. Work to complete documentation of deviations and events in appropriate systems
• Participate in shift exchanges, 1-1’s, department meetings, attend meetings as necessary to facilitate area needs based on changes, etc.

This position requires regular onsite attendance in order to satisfactorily perform duties.

How will you get here?

• Bachelor’s degree in Biology, Biochemistry or Chemistry.
• No experience required, but 1-3 years of relevant lab experience in a related field or industry preferred
• Experience in cGMP environment preferred
• Experience with using an autoclave, water testing and environmental monitoring in ISO classified areas seen as a plus

• Knowledge

• Understanding ‘why’ and not just the ‘how’ of processes and practices
• Knowledge of cGMP practices, aseptic techniques, or microbiological concepts seen as a plus
• Knowledge of industry standards such as ISO, ICH, FDA and USP

• Skills

• MS Office (Word, Excel, Power Point,etc)
• Strong prioritization skills
• Detail oriented
• Results driven
• Investigation and experience with Root Cause analysis, preferred

• Abilities

• Able to read, write, and communicate in English
• Able to understand and carry out instructions
• Reliable
• Effective communication (written and verbal)
• Effectively multi-task
• Able to work in an environment of change
• Able to work independently and as part of a team
• Acknowledge when problems are developing, not just occurring

• At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

  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.