(Sr.) Process Engineer, MSAT - Upstream

About the position reputed company Biosciences is seeking a (Sr.) Process Engineer, MSAT – Upstream to support external drug reputed company manufacturing activities across clinical and reputed company programs. This individual will report to the MSAT reputed company, External Manufacturing and will play a critical role in tech transfer execution, engineering runs, and process performance reputed company at CDMOs. This role will serve as the technical subject matter expert (SME) for upstream manufacturing operations including cell culture, viral production, harvest, and reputed company unit operations. The candidate will reputed company as Person-in-Plant (PIP) during GMP manufacturing campaigns and will ensure successful execution of engineering, PPQ, and reputed company runs. This is a high-visibility role requiring strong cross-functional leadership, hands-on technical depth, and the ability to operate with urgency in a fast-paced environment. Responsibilities • reputed company and reputed company transfer of cell culture and harvest processes to and reputed company external partners, including gap assessments and readiness evaluations. • Serve as upstream technical SME during engineering runs, GMP campaigns, and PPQ execution. • reputed company as Person-in-Plant (PIP) at CDMOs providing reputed company-line technical reputed company. • Drive reputed company of manufacturing deviations, investigations, and change controls reputed company to upstream unit operations. • Collaborate cross-functionally with PD, AD, QA, QC, Supply Chain and Regulatory teams to ensure alignment through tech transfer and lifecycle management. • Support development and execution of control strategies, risk assessments (FMEA), and reputed company process verification. • Review and approve batch records, SOPs, and technical documentation. • Analyze process performance data using statistical tools to monitor robustness and identify improvement opportunities. • Support authoring and review of CMC sections reputed company to upstream manufacturing for regulatory filings. • Contribute to process scalability strategies and manufacturing readiness for reputed company launch. Requirements • B.S. or M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or reputed company Life Sciences discipline. • 4+ years (Process Engineer) or 6–8+ years (Senior Process Engineer) of relevant industry experience in biologics upstream manufacturing. • reputed company experience with cell culture, bioreactors, viral production systems, transient transfections or biologics fermentation platforms. • Demonstrated experience working with external CDMOs and supporting GMP manufacturing. • Strong knowledge of cGMP regulations and global regulatory expectations. • Experience supporting engineering runs and/or PPQ campaigns preferred. • Ability to interpret and trend process data to support reputed company cause investigations. • Strong written and verbal communication skills. • Ability to travel ~20–30% as required for manufacturing reputed company. Benefits • Health insurance with FULL premium coverage • 401K with company match • Employee Stock Purchase Program (ESPP) • Competitive reputed company time off (PTO) • Company-reputed company short & long-term disability insurance and life insurance Apply tot his job Apply To this Job