Process Engineer - API ManufacturingKelly Science, Engineering, Technology & Telecom • Saint Louis, MO, US
Process Engineer - API Manufacturing
Kelly Science, Engineering, Technology & Telecom • Saint Louis, MO, US
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job_description.job_card.job_descriptionBS 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.
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
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science, Consulting, and Analyst
Industries
Pharmaceutical Manufacturing
J-18808-Ljbffr
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Manufacturing Engineer • Saint Louis, MO, US