Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Location/Division Specific InformationThermo 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.
We are searching for a Continued Process Verification (CPV) Engineer III with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological and statistical input in the validation and continued process verification of manufacturing processes. A CPV Engineer 3 routinely supports the Manufacturing Sciences and Technology team as a technical owner of commercial customer programs in a manufacturing environment and will assist in defining and shaping Thermo Fisher Scientific's continued process verification. expert in statistics and data analysis. This role will collaborate internally with Process Engineers, Quality Assurance, and Regulatory. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.
Responsibilities:
- Perform all functions associated with process validation support, with a specific focus on CPV
- Establish global CPV initiatives and standard practices
- Act as the primary biostatistician in supporting Process Engineering and Process Development DoE studies
- Manage the scope, schedule, and reporting of CPV program activities
- Participate in Customer and Regulatory Audits
- Draft, review, and approve CPV plans, CPV reports, and APQRs
Requirements:
- Bachelor's degree in a scientific field, preferably an engineering field
- 5+ years of experience in the GMP regulated Biologics/Pharma Industry or equivalent (or master's degree + 2 years' experience or Ph.D.)
- Experience with process validation
- Strong foundation in general scientific practices, principles, and concepts
- Excellent written and verbal communication skills
- Ability to work independently and collaboratively as part of a team
- Proficiency in statistical analysis software programs such as JMP
- Proficient in Microsoft Word and Excel
Must be able to pass a comprehensive background check, which includes a drug screening.
