Process Engineer - 1099 or W

• Do you find satisfaction in building trust before driving change?
• Do you enjoy helping teams evolve at a pace they can sustain, not just accelerate?
• Can you guide others through change without forcing it?
• Are you comfortable working in environments where relationships matter as much as results?
• Do you take pride in mentoring others and raising the capability of a team over time?

• Do you find satisfaction in building trust before driving change?
• Do you enjoy helping teams evolve at a pace they can sustain, not just accelerate?
• Can you guide others through change without forcing it?
• Are you comfortable working in environments where relationships matter as much as results?
• Do you take pride in mentoring others and raising the capability of a team over time?

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 Bio Tech 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

• 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.
• Own Project Engineering scope across the full project lifecycle - maturing URS/specification quality in partnership with the site team, vendor identification and assessment, and equipment installation activities (FAT/SAT, IOQ/PQ) - bridging process and project engineering rather than working in a silo.
• Build the business case for process and capital improvements with quantifiable results (cost savings, capacity gains, risk reduction) to support site funding decisions.

• 10-15 years of process engineering experience in an FDA-regulated or similarly controlled manufacturing environment.
• Demonstrated change leadership - proven ability to earn trust on the floor, guide operators and technical teams through process and organizational change, and sustain momentum without forcing it.
• 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 owning capital/small-cap project scope end-to-end - budget, schedule, design, and…