- 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 BioTech 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 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.
Requirements:
- 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 construction oversight – while staying grounded in the process itself.
- 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.
- Experience developing the capability of others – mentoring engineers, co-ops, or technicians and elevating team performance over time.
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.
