Note: The job is a remote job and is open to candidates in USA. GMP Pros® is a start-up supporting leading pharmaceutical, biotech, food, and animal health companies. They are seeking a seasoned Process Engineer to provide process engineering support in manufacturing and packaging, troubleshoot issues, and support project engineering initiatives in a BioTech environment.
Responsibilities
- Provide process engineering support across production processes
- Troubleshoot process and equipment issues directly with operators, mechanics, supervisors, and technical teams
- Lead or support investigations, root cause analysis, and corrective actions tied to deviations, recurring losses, or process failures
- Support validation-related activities, continued process verification, process monitoring, and change implementation as needed
- Partner with QA, QC, Maintenance, Engineering, and Operations to keep processes controlled, reliable, and execution-ready
- Support line trials, startup/ramp-up activities, and technical improvements tied to throughput, quality, reliability, and waste reduction
- Help connect upstream manufacturing conditions with downstream packaging performance so issues are solved at the actual source
- Support Project Engineering across the project lifecycle from URS/specification development to vendor identification and assessment, to equipment installation activities (FAT/SAT, IOPQ)
Skills
- 7–10+ years of process engineering experience in an FDA-regulated or similarly controlled manufacturing environment
- Demonstrated SME-level knowledge and experience supporting Biological processes, including aseptic filling
- Strong troubleshooting capability in live production environments
- Experience with deviations, investigations, root cause analysis, change control, and technical process improvement
- Demonstrated experience with the validation lifecycle
- Working knowledge of project engineering principals and proven experience across the project lifecycle
- Comfort working on-site full time and moving between multiple production areas throughout the day
- Ability to work directly with operators and site teams in a practical, hands-on support role
- Bachelor's degree in Chemical, Mechanical, Industrial, or related Engineering discipline
- Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references
- Subject to motor vehicle report review
- Maintain valid driver's license and endorsements as required per position
- Pass pre-employment/contract physical, medical evaluation, and drug screen due to the safety sensitive nature of this position
- Successfully complete and maintain any required safety certification and testing on an annual basis
- Experience with line trials, technology transfer, startup support, or new product introduction
- Exposure to continued process verification, FMEA, Lean, TPM, centerlining, or reliability improvement methods
- Experience using plant systems or reporting tools such as SAP, MES, or Power BI
Company Overview