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Job DescriptionAs 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. 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?
Perform routine environmental monitoring of viable/non-viable air, contact surface, water, and gases in accordance with site SOPs and policies.
Documentation of all activities to meet cGMP requirements.
Execute 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.
Perform equipment testing and routine troubleshooting.
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?Education:
Minimum required education: Bachelor’s degree in biology, Biochemistry or Chemistry
Experience:
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, 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.)
Strong prioritization skills
Detail oriented
Results driven
Investigation and experience with Root Cause analysis, preferred.
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
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.comThermo 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 AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.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.
Full-time