Scientist I, Microbiology

Employer
Thermo Fisher Scientific
Location
Carlsbad, California, US
Salary
Competitive
Posted
Apr 28, 2021
Closes
Jun 03, 2021
Ref
1924761143
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
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
This position will work in the cGMP compliant QC Microbiology Laboratory supporting manufacture of biological products. Responsibilities include performing and providing support for functional aspects of the facility such as environmental monitoring (EM), microbiological testing (bioburden, bacterial endotoxin testing, growth promotion, biological indicators, stock cultures), media fills, water testing and validation support.
How will you make an impact?
The incumbent will be expected to write and technically interpret controlled documents and reports, and review data produced by self and initiate investigations. Will interact with other departments to ensure that environmental monitoring scheduling and sample flow, are correctly maintained.
Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained. Will assist with qualifications (equipment, media, clean room, etc..). Will assist with Test Record and SOP revisions. Will assist in writing reports.
What will you do?
- Perform environmental monitoring of a biological production facility according to written procedures, while fully gowned, including operational monitoring and personnel monitoring during aseptic processing and filling.
- Oversee aliquoting/sterile filling operations and ensure acceptable aseptic techniques are employed on the floor.
- Qualify and perform microbiological testing such as bioburden, bacterial endotoxin and biological indicator testing
- Draft SOPs, Test Records, Qualification Protocols, OOS Environmental Investigations and Summary reports and any supporting documents (Reagent Preparations, Equipment SOPs etc)
- Review data EM data, analyze and summarize data with guidance.
- Order laboratory supplies and maintain required inventory according to SOPs
- Perform laboratory and equipment cleaning and preventive maintenance and calibration
- Read and report microbiological test results
- Perform Gram stains and arrange shipments of samples to contract labs for identification
- Maintains and ensures safe laboratory practices. Also drafts and reviews Job Hazard Analysis for assays.
- Other assigned duties could include sample logging and assisting with shipment preparations
Work performed would support GMP manufacturing activities and release testing. This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.
How will you get here?
Education
- A Bachelor's degree in Life Sciences or Chemical/Biological Engineering.
- LIMS experience preferred
Experience
- A minimum of one year of work experience within the biological and/or pharmaceutical industry. A graduate degree and appropriate hands-on college coursework may substitute at an equivalent rate for required experience
- Laboratory documentation, reports, and correspondenceHands on experience with aseptic technique, light microscopy, bioburden testing, bacterial endotoxin testing and general microbiological techniques. Familiarity with microbial taxonomy and identification.
Knowledge, Skills, Abilities
- Electronic organizational skills using Microsoft Excel, Word, Power Point or other planning tools
- Basic knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment
At Thermo Fisher Scientific, each one of our 75,000 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 Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.