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.
How will you make an impact?
The scientist will be responsible for the performance of tasks in support of the manufacture of Commercial and Clinical Biologics and 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?
- Perform routine Environmental Monitoring of viable/non-viable air, contact surface, water, and gases
- Documentation of all activities to meet cGMP requirements.
- Complete document reviews and revisions.
- Interpret data results in accordance with 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.
- Ensure tasks are performed 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.
How will you get here?
Education:
- Associates Degree and 2+ years of relevant work experience
- Bachelor’s degree with no experience, STEM degree preferred
Experience:
- 1-3 years of 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 preferred
Knowledge, Skills, and Abilities:
- 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
- MS Office (Word, Excel, Power Point, etc.)
- Investigation and experience with Root Cause analysis, preferred.
- Able to read, write, and communicate in English.
- Effectively multi-task
- Ability to work independently and as part of a team
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 global 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.
Accessibility/Disability Access
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