Biotech Process Engineer - Manufacturing & Packaging

• Do you want to get out of the corporate grind of meetings?
• Do you excel at leading large capital projects that require you to be a great planner, negotiator, and change leader?
• Are you up to the challenge of leading the transformation of a facility?

• Do you want to get out of the corporate grind of meetings?
• Do you excel at leading large capital projects that require you to be a great planner, negotiator, and change leader?
• Are you up to the challenge of leading the transformation of a facility?

This is an opportunity to support both manufacturing and packaging projects for a massive biotech facility in the Midwest. This person must be able to troubleshoot in real time with operators, stabilize processes, support validation/change-related activities, and bring strong experience in OTC powders and oral solid dose (OSD) environments.

Be part of an exciting start-up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. Get the best of both worlds. Gain experience at a company that leads projects for global pharmaceutical companies while enjoying the flexibility, energy, and personal attention that can only be found working in a small, close-knit company.

APPLICANTS MUST HAVE PRIOR EXPERIENCE IN BIOTECH, PHARMACEUTICAL, OR ANIMAL HEALTH INDUSTRIES TO BE CONSIDERED

Essential Duties

• 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.

Strongly Preferred

• 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.

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.

#J-18808-Ljbffr