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Recruit123 is seeking a Senior Process Engineer, MSAT to bridge process development and commercial manufacturing for biologics. You will lead tech transfer activities, define scale-up/down parameters for bioreactors and purification platforms, and drive CPV and process verification lifecycle.
The role requires 5–8 years in MSAT/process engineering within a regulated biopharma environment, with deep expertise in either upstream culture or downstream purification and strong data analysis skills
Recruit123 is currently partnering with a leading global biopharmaceutical manufacturer to hire a Senior Process Engineer, MSAT (Manufacturing Science and Technology).
This is an exciting opportunity to serve as the technical subject matter expert (SME) bridging process development and commercial manufacturing, driving technology transfers, process lifecycle management, and complex technical troubleshooting for both upstream and downstream unit operations.
In this role, you will lead end-to-end technical support for commercial and clinical-scale biologics production, ensuring robust process performance, yield optimization, and continuous process verification (CPV).
Your main day-to-day responsibilities will include leading tech transfer activities, defining scale-up and scale-down parameters for bioreactor systems or downstream purification platforms (chromatography, TFF/UFDF, filtration), and executing process validation protocols. You will spearhead root cause analyses (RCA) and complex deviation investigations, design small-scale laboratory experiments to troubleshoot floor issues, and author comprehensive technical justification memos, change controls, and regulatory filings.
Additionally, you will partner cross-functionally with Manufacturing, Quality, Regulatory, and Global MSAT teams to implement process improvements, statistical process control (SPC) models, and advanced manufacturing technologies.
We are seeking candidates with a degree or postgraduate qualification in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline, alongside at least 5 to 8 years of MSAT or process engineering experience within a regulated cGMP biopharmaceutical environment.
You should demonstrate deep technical mastery in either upstream cell culture/fermentation or downstream purification, accompanied by proven expertise in scale-up methodologies, tech transfer execution, and statistical data analysis (e.g., Minitab, JMP, SIMCA).
Strong stakeholder management, high-level technical writing capabilities, and the agility to navigate fast-paced operational challenges and cross-functional leadership are essential.