Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Location/Division Specific Information
Thermo 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 IIIwith 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.
