Contract Process Engineer — GMP Pharma Manufacturing

i-Pharm GxP; Charlotte (NC); On-site; USD 90,000 - 120,000; Part time

Job summary

i-Pharm GxP is seeking a Contract Process Engineer for a 12-month assignment at our Charlotte, NC site. You will own and optimize manufacturing processes across upstream/downstream operations, with focus on yield, quality, and efficiency in a GMP environment.

This role offers hands-on technical ownership on an active production site, with clear path for career growth and exposure to validation, tech transfer, and continuous improvement initiatives. W2 contract, 40 hours/week, with OT available.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related discipline.
• 2+ years of process engineering experience in a cGMP pharmaceutical, biotech, or regulated manufacturing environment.
• Experience with deviation/CAPA systems and root cause analysis tools.

Responsibilities

• Own and optimize manufacturing processes across upstream/downstream operations, or formulation/fill-finish, packaging as applicable.
• Lead root cause investigations and CAPA implementation for process deviations.
• Partner cross-functionally with Quality, Validation, Automation, and Manufacturing teams to troubleshoot production issues.
• Author and execute protocols for process validation, tech transfer, and equipment qualification (IQ/OQ/PQ).
• Apply Lean/Six Sigma methodologies to reduce cycle times and variability.
• Ensure compliance with cGMP, FDA, and regulatory standards.
• Support scale-up and technology transfer into commercial manufacturing.

Skills

2+ years process engineering

Unit operations

Process validation

Regulatory documentation

Cross-functional communication

W2/contract availability

Education

Bachelor's degree in Chemical/Biochemical Engineering or related

Tools

Deviation/CAPA systems

Root cause analysis tools

Job description

i-Pharm GxP is seeking a Contract Process Engineer for a 12-month assignment at our Charlotte, NC site. You will own and optimize manufacturing processes across upstream/downstream operations, with focus on yield, quality, and efficiency in a GMP environment.

This role offers hands-on technical ownership on an active production site, with clear path for career growth and exposure to validation, tech transfer, and continuous improvement initiatives. W2 contract, 40 hours/week, with OT available.