Demo

Process Engineer

Rangam
St. Louis, MO Full Time
POSTED ON 3/8/2025
AVAILABLE BEFORE 6/8/2025

Are you an experienced Process Engineer with a background in biologics development and commercial manufacturing ? We are seeking a skilled professional to provide technical support, process validation, and lifecycle management for commercial biologics processes. This role is primarily remote , but candidates must be local to St. Louis, MO , with occasional onsite visits to a local Contract Manufacturing Organization (CMO) .

Why Join Us?

  • Work with a global leader in biologics manufacturing
  • Engage in cutting-edge bioprocess engineering, lifecycle management, and technology transfer
  • Opportunity to support a diverse portfolio of commercial and pipeline biologics
  • Potential for extension and travel reimbursement for Framingham, MA visits

Key Responsibilities :

  • Provide technical support and process monitoring for commercial biologics manufacturing at CMOs
  • Conduct root cause analysis, risk assessments, and process validation following GMP guidelines
  • Perform onsite person-in-plant observations and communicate findings to the product team
  • Review manufacturing processes, deviations, batch records, protocols, and control strategies
  • Support investigations, deviation resolution, and process improvement initiatives
  • Collaborate with cross-functional teams in Engineering, Manufacturing, and Quality departments
  • Oversee and report on manufacturing progress and compliance with industry best practices
  • Must-Have Qualifications :

  • Bachelor’s degree in Engineering or Science with 5 years of experience in Process Engineering at a Pharma / Biotech company
  • OR Master’s degree with 3 years of experience in a similar role
  • OR PhD candidates with 3 years of relevant industry experience
  • Hands-on experience in biologics development, process validation, and manufacturing operations
  • Strong understanding of GMP, root cause analysis, risk assessment, and lifecycle management
  • Nice-to-Have Qualifications :

  • Experience supporting GMP, MSAT, or commercial biologics processes
  • Direct lab experience in cell culture, downstream purification, or bioprocess engineering
  • Familiarity with equipment qualification and process validation
  • Experience with statistical analysis software and investigative data analysis
  • Strong technical writing, project leadership, and communication skills
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