Process Engineer

Target Pay Rate:

$35.00 - $42.00/hour (W2)

PTO, Paid Holidays, Medical/Dental/Vision Plans, 401(k), ESOP

Deviations, CAPAs, change control, and GMP documentation

The Process Support Engineer supports commercial pharmaceutical manufacturing operations by ensuring processes are compliant, robust, and continuously improving. This role focuses on process documentation, deviation investigations, CAPAs, and change management, working closely with Manufacturing, Quality, Validation, and Engineering in a GMP environment.

• Provide day-to-day process engineering support for GMP manufacturing operations
• Lead and support deviation investigations, root cause analysis, and CAPA implementation
• Author, review, and maintain GMP documentation (SOPs, batch records, work instructions, protocols, reports)
• Support change controls, including impact assessments and cross-functional coordination
• Partner with Manufacturing, Quality, and Engineering to troubleshoot issues and drive continuous improvement
• Monitor processes, analyze trends, and support manufacturing readiness and process control
• Maintain compliance with GMP/GDP requirements and ensure audit-ready documentation
• Provide floor support and contribute to inspections, audits, and regulatory interactions as needed

• Bachelor’s degree in Engineering or Science (Chemical Engineering preferred)
• Experience supporting commercial pharmaceutical manufacturing in a GMP environment
• Hands-on experience with deviations, CAPAs, change control, and GMP documentation
• Strong understanding of quality systems and regulatory expectations
• Proven analytical, technical writing, and cross-functional communication skills
• Self-directed and detail-oriented, with the ability to thrive in a fast-paced manufacturing setting

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.