- Does navigating organized chaos - where you're pulled into meetings, solving cross-functional challenges, and balancing compliance with agility - excite you?
- Does the ideal of balancing strict compliance with agile solutions excite you as you help an organization rapidly become more efficient?
- Are you energized by an environment where you'll juggle everything - from deviations to cross-functional problem solving - all before lunch?
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.
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.
- 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.
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.
