What are the responsibilities and job description for the RCI-SNFI-9629 Process Engineer - Saint Louis, MO RCI-SNFI-9629 Process Engineer - Saint Louis, MO (REMOTE) position at Rangam?
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
Salary : $78 - $81
