Process Engineer - 1099 or W-2

About the role

We are looking for a seasoned, floor-oriented Process Engineer who can support both manufacturing and packaging. This person must be able to troubleshoot in real time with operators, stabilize processes, support validation/change-related activities, understand and support project engineering initiatives (project lifecycle), and bring strong experience in BioTech environments.

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)

Requirements

• 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.
• Strongly Preferred: 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.

Pre-Employment Requirements

• 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.

Work Environment Expectations

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.