Process Development Engineer - Kilo/Pilot Plant
Listed on 2026-09-02
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Engineering
Process Engineer, Chemical Engineering, Quality Engineering
The Engineer will partner with a multi-functional group of engineers and scientists through the process development cycle at Client to develop and optimize synthetic unit operations aligned for the intended phase of technology transfer and commercial support. This includes experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and support of kilo lab operations during process execution and equipment commissioning.
Domestic and International Travel:
This role does not require travel.
The Engineer will be expected to:
- Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in state-of-the-art facilities.
- Initiate and complete technical tasks in lab, kilo/pilot plant
- Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization.
- Function as a technical expert to equipment or systems regarding troubleshooting
operations.
- Suggest problem resolution, provide troubleshooting guidance and recommend process improvements.
- Apply engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements.
- Communicate and collaborate with Manufacturing, Process Development, and Quality departments.
- Contribute to key regulatory and quality activitie s such as non-conformance, process performance qualification and continued process verification.
We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.
Basic QualificationsBachelor’s degree and 2 years of Engineering or Operations experience Or
Associate’s degree and 6 years of Engineering or Operations experience Or
High school diploma / GED and 8 years of Engineering or Operations experience
Preferred Qualifications:- Academic background in Chemical Engineering
- 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of synthetic manufacturing processes
- Experience in peptide and/or oligonucleotide process development and manufacturing is preferred.
- Hands-on experience with Prep LC, AEX, HIC, TFF, and UF/DF purification processes.
- Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
- Basic understanding of cGMP requirements
- Experience building and utilizing first principal models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
- Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
- Background in statistical analysis/DoE
- Working knowledge of standard plant operations and safety practices
- Excellent project management skills
- Strong verbal communication and presentation skills
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