Kelly Science, Engineering, Technology & Telecom
Process Engineer – API Manufacturing
Kelly Science, Engineering, Technology & Telecom, Saint Louis, Missouri, United States, 63146
Lead API Scale-Up in a Cutting-Edge GMP Facility
Title:
Process Engineer – API Manufacturing Location : St. Louis, MO Pay Rate : $45-50/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. 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. 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. Seniority level : Mid-Senior level Employment type : Full-time Job function : Science, Consulting, and Analyst Industries : Pharmaceutical Manufacturing
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Process Engineer – API Manufacturing Location : St. Louis, MO Pay Rate : $45-50/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. 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. 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. Seniority level : Mid-Senior level Employment type : Full-time Job function : Science, Consulting, and Analyst Industries : Pharmaceutical Manufacturing
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