United Consulting HubRemote
Process Engineer
United States of America
Contract
2 days ago
H1B Sponsor Likely
Key skills
Chemical Engineering principlesBiotechnology manufacturing processesPharmaceutical manufacturing processesLaboratory PracticesProcess equipmentExcelMinitabDocumentation PracticesR
About this role
United Consulting Hub is seeking a motivated entry-level Process Engineer to support manufacturing and process optimization in a regulated pharmaceutical or life sciences environment. The role involves working with cross-functional teams to improve efficiency, ensure compliance, and maintain product quality.
Responsibilities:
- Assist in developing and optimizing manufacturing processes for drug products (solid, liquid, or biologics)
- Support process validation activities (IQ, OQ, PQ – Installation, Operational, Performance Qualification)
- Monitor production processes and identify improvement opportunities
- Ensure compliance with Good Manufacturing Practice (GMP) and FDA guidelines
- Analyze process data and prepare technical reports
- Troubleshoot deviations, CAPA (Corrective and Preventive Actions)
- Collaborate with Quality Assurance (QA) and Quality Control (QC) teams
- Participate in technology transfer from R&D to manufacturing
- Maintain documentation for audits and regulatory submissions
Requirements:
- 0-2 years of experience
- Motivated entry-level Process Engineer
- Support manufacturing and process optimization in a regulated pharmaceutical or life sciences environment
- Assist in developing and optimizing manufacturing processes for drug products (solid, liquid, or biologics)
- Support process validation activities (IQ, OQ, PQ – Installation, Operational, Performance Qualification)
- Monitor production processes and identify improvement opportunities
- Ensure compliance with Good Manufacturing Practice (GMP) and FDA guidelines
- Analyze process data and prepare technical reports
- Troubleshoot deviations, CAPA (Corrective and Preventive Actions)
- Collaborate with Quality Assurance (QA) and Quality Control (QC) teams
- Participate in technology transfer from R&D to manufacturing
- Maintain documentation for audits and regulatory submissions
- Basic understanding of Chemical Engineering principles (mass transfer, thermodynamics)
- Basic understanding of Biotechnology or pharma manufacturing processes
- Knowledge of Good Laboratory Practices
- Knowledge of Good Documentation Practices
- Familiarity with process equipment (reactors, fermenters, filtration systems)
- Basic data analysis (Excel, Minitab preferred)