Scientist III - Continuous Process Verification

ThermoFisher Scientific; St. Louis (MO); On-site; USD 110,000 - 150,000; Full time

Job summary

Thermo Fisher Scientific in St. Louis, MO, seeks a continued process verification (CPV) Engineer III to join Manufacturing Sciences and Technology. You’ll provide statistical input, validate processes, and guide CPV activities within cross-functional teams.

Ideal candidates have 5+ years in GMP biologics/pharma, strong JMP proficiency, and excellent communication. The role collaborates with Process Engineers and QA to ensure program success.

Qualifications

• Bachelor's degree in a scientific field; engineering preferred.
• 5+ years GMP regulated Biologics/Pharma experience or equivalent.
• 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.

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.

Skills

Statistical analysis

Written communication

Verbal communication

Teamwork

Education

Bachelor's degree in a scientific field

Master's degree or PhD in related field

Tools

JMP

Microsoft Word

Microsoft Excel

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

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.

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 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.

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.