Process Engineer 1099 or W-2
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
- Does navigating organized chaos - where youre 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 youll juggle everything - from deviations to cross-functional problem solving - all before lunch
This is an opportunity to support both manufacturing and packaging projects for a massive pharmaceutical manufacturing 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 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 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 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.
Requirements:
- 710 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.
- Bachelors 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 processvalidationlifecycle execution 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
Key Skills
About Company
We are a leading FDA regulatory compliance monitoring & consulting agency, ensuring high standards in the development, testing & labeling processes. Contact us today.
