Process Engineer u2013 API Manufacturing

Lead API Scale-Up in a Cutting-Edge GMP Facility Title: Process Engineer u2013 API Manufacturing Location: St. Louis, MO Pay Rate: $45-55/hr. _Contract-to-Hire_ About the Role Weu2019re seeking a Process Engineer with 3-7 yearsu2019 experience in GMP API manufacturing. Youu2019ll 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 As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly u00ae Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worldu2019s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsu2014itu2019s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, weu2019re obsessed with where it can take you. To us, itu2019s about more than simply accepting your next job opportunity. Itu2019s the fuel that powers every next step of your life. Itu2019s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your lifeu2014just ask the 300,000 people we employ each year. 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We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellyu2019s Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Created: 2025-12-08