Process Engineer - 1099

GMP Pros® is a company that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. They are seeking a Process Engineer to provide engineering support across manufacturing and packaging operations for a large biotech facility, focusing on troubleshooting, process stabilization, and validation activities.

Responsibilities:

• Provide process engineering support across both manufacturing and packaging operations
• 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

Requirements:

• 7–10+ years of process engineering experience in an FDA-regulated or similarly controlled manufacturing environment
• Demonstrated experience supporting both manufacturing and packaging operations
• Strong troubleshooting capability in live production environments
• Experience with deviations, investigations, root cause analysis, change control, and technical process improvement
• 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
• This role is expected to be on-site full time at the Client facility
• The individual must be comfortable entering various manufacturing and packaging areas as needed to support operators and troubleshoot issues
• This is a hands-on site support role, not a primarily remote or conference-room-based engineering assignment
• Direct experience with OTC powder manufacturing operations
• Direct experience with oral solid dose (OSD) products and associated process/equipment challenges
• Familiarity with manufacturing and packaging equipment commonly used in powder and OSD environments
• Experience with line trials, technology transfer, startup support, or new product introduction
• Exposure to process validation lifecycle execution, 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