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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.
What you will be doing:
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.
What we are looking for:
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.
Recruiter Information
Recruiter: Lian Cher Chieh UEN: 202511044R License No.: 25C2810EA Registration No: R1217705
Job ID: 153434863
Skills:
Metrology Tools Type Expertise in Thin Film Critical Dimension and Resistivity, Metrology Process, Technology Transfer Experiences with Fab-Specific Metrology Tools Measurement Systems and Applications, Quality Knowledge, Training Tools and Certification Example JMP FMEA DOE and 8D, SPC Knowledge
Skills:
SAP, Non-Ferrous Metal Processing, Cold Rolling, Machine Commissioning, Process Engineering, Lean Manufacturing, Six Sigma, Process Control
Skills:
engineering change , Plastic injection molding, Process improvement, Capability studies, Troubleshooting, Fault Finding
Skills:
Matlab, SOP technical documentation, Data Analysis, Process Optimization, Doe, Semiconductor front end, Hybrid bonding, Jmp, MS-Office
Skills:
Microsoft Office, Edi, ion exchange, Commissioning, process optimisation, Autocad, EPC project design, water treatment, process simulation software, Desalination, Process Engineering, membrane technologies, biological treatment processes, hydraulic modelling tools