Process Engineer

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

Process Engineer — Pharmaceutical Manufacturing (Charlotte, NC)

Initially 12-month contract, with likely future extension

Location: Charlotte, North Carolina

Employment Type: 40 Hours/week, O.T. Available, W2, No Sponsorship

Industry: Pharmaceutical / Biopharmaceutical Manufacturing

About the Opportunity

i-Pharm GxP is partnering with a well-established pharmaceutical manufacturer with a growing production site in Charlotte, NC, is looking for a Contract Process Engineer. This is a chance to work on high-impact, GMP-regulated production processes that directly support the supply of critical medicines — with strong visibility, technical ownership, and a clear path for career growth.

As a specialist SOW consultancy, i-Pharm GxP places engineers on a project/deliverables basis — this role offers genuine technical ownership and the chance to make a fast, visible impact on an active production site.

What You’ll Do

• Own and optimize manufacturing processes across upstream/downstream operations (or formulation, fill-finish, packaging — tailor to actual process), driving yield, quality, and efficiency improvements


• Lead root cause investigations and CAPA implementation for process deviations


• Partner cross-functionally with Quality, Validation, Automation, and Manufacturing teams to troubleshoot production issues in real time


• Author and execute protocols for process validation, tech transfer, and equipment qualification (IQ/OQ/PQ)


• Apply continuous improvement and Lean/Six Sigma methodologies to reduce cycle times and variability


• Ensure all activities comply with cGMP, FDA, and relevant regulatory standards


• Support scale-up and technology transfer of new products into commercial manufacturing

What You Bring

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related discipline (advanced degree a plus)


• 2+ years of process engineering experience in a cGMP pharmaceutical, biotech, or regulated manufacturing environment


• Strong understanding of unit operations, process validation, and regulatory documentation


• Experience with deviation/CAPA systems and root cause analysis tools


• Excellent cross-functional communication skills and comfort working on the production floor


• Ability to work on a W2/contract basis for the duration stated

Why Join

• Work on products that make a direct impact on patient health


• Join a site investing heavily in modernization and expansion


• Competitive compensation, strong benefits, and genuine growth trajectory into senior/lead engineering roles

Client name withheld at this stage of the search — happy to share full details with shortlisted candidates.