Process Engineer 1099

• 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 worlds 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 acrossproduction 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 andexecution-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 packagingperformanceso issues are solved at the actual source.

• Support Project Engineering across the project lifecyclefrom URS/specification development to vendor identification and assessment to equipment installation activities (FAT/SAT IOPQ)

Requirements:

• 710 years of process engineering experience in an FDA-regulated or similarly controlled manufacturing environment.

• DemonstratedSME-level knowledge andexperience supportingBiologicalprocesses 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 thevalidationlifecycle.

• Working knowledge of project engineeringprincipalsand 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.
• Bachelors 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 TPMcenterlining or reliability improvement methods.

• Experience using plant systems or reporting tools such as SAP MES or Power BI.

Pre-EmploymentRequirements:

• Pass and maintain pre-employment/contract background check and safety certification including but not limited to outstanding professional references.
• Subjecttomotorvehiclereportreview.
• Maintainvaliddriverslicenseandendorsementsasrequiredperposition.
• 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-sitefull-timeat theClientfacility.

• 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.

Required Experience:

IC