Process Engineer - API Manufacturing

Process Engineer - Api Manufacturing

Lead API Scale-Up in a Cutting-Edge GMP Facility!

Location: St. Louis, MO

Pay Rate: $45-55/hr.

Contract-to-Hire

About the Role

We're seeking a Process Engineer with 3-7 years' experience in GMP API manufacturing. You'll translate bench chemistry into robust, plant-ready processes, optimize yield/quality, and support tech transfers across kilo lab, pilot, and commercial scales. Experience with continuous manufacturing platforms and designing/identifying scalable equipment will be key as we expand capabilities. Occasional travel to customer sites is expected.

Key Responsibilities

• Scale-up & Tech Transfer: Convert lab procedures to scalable unit operations (reaction, crystallization, filtration, drying), author/execute transfer packages and PPQ protocols.
• Continuous Manufacturing: Develop, implement, and optimize continuous processes for small-molecule APIs, ensuring robustness and regulatory compliance.
• Equipment Design & Scale: Evaluate, design, and/or identify appropriate scalable equipment for lab, pilot, and commercial applications; partner with engineering to ensure fit-for-purpose systems.
• Validation & Compliance: Lead/author process validation docs, batch records, change controls; investigate deviations/OOS and drive CAPA.
• Cross-Functional Collaboration: Work closely with R&D/Analytical, QA/QC, Supply Chain, and external customers to meet timelines and CQA/CQPs.
• Documentation: Write SOPs, reports, and technical summaries suitable for regulatory inspections.

Qualifications

• BS in Chemistry, Chemical Engineering or related discipline
• 3-7 years in GMP small-molecule API manufacturing/scale-up
• Bench chemistry background with strong understanding of reaction mechanisms, impurity control, and crystallization science
• Solid grasp of cGMP, data integrity, and regulatory expectations; strong technical writing
• Hands-on experience with continuous manufacturing approaches and equipment design/selection for scale-up strongly preferred