CPV Engineer III: Biopharma Process Validation & Stats

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

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.