Sr Engineer, Process

Overview As Sr Engineer, Process you will lead hands-on process engineering on the GMP vaccine drug substance floor, ensuring safe, reliable operations. You’ll troubleshoot real-time deviations and drive sustainable CAPAs, partnering with Manufacturing, MS&T, Quality, and Facilities. You support technology transfers, process optimization, and lifecycle engineering to meet regulatory expectations. This role offers exposure to end-to-end process lifecycle and opportunities to shape manufacturing excellence at scale. Compensation / Benefitscomprehensive benefits packagebase salary with potential merit increasesannual bonuslong-term incentives (stock options)opportunity to contribute to mission-driven work ResponsibilitiesProvide real-time process engineering support on the GMP vaccine drug substance operations (upstream, downstream, support systems)Lead troubleshooting of process and equipment deviations and implement CAPAsServe as process owner and SME for assigned unit operations and systemsSupport and lead process improvements, optimization initiatives, and capacity enhancementsAuthor, review, and approve GMP documentation (deviations, change controls, risk assessments, protocols, reports)Support technology transfer activities including process characterization and readiness for new/modified processesLead or execute commissioning, qualification, validation (FATs, SATs, PPQ)Coordinate with Quality Assurance to ensure alignment with Quality Systems and data integrityProvide technical input during regulatory inspections and auditsCollaborate with vendors, contractors, and internal teams for reliability and lifecycle managementMentor junior engineers and contribute to engineering standards and knowledge sharing Key requirements7–10 years of progressive process engineering experience in GMP-regulated biopharmaceutical or vaccine drug substance manufacturingHands-on floor support and real-time troubleshooting in GMP environmentsStrong knowledge of vaccine/biologics unit operations (upstream, downstream, CIP/SIP, single-use tech)Deep understanding of GMP regulations, validation lifecycle, change/deviation management, and data integrityExperience with process design and engineering docs (PFDs, P&IDs, URS, FMEA, equipment specs)Ability to apply engineering principles to complex manufacturing problems using root cause and risk toolsEffective communication with Manufacturing, Quality, Regulatory, and leadershipProficiency with engineering/ERP tools (AutoCAD, MS Office, electronic quality systems, SAP preferred)Willingness to work in a fast-paced environment and provide on-call/off-shift supportBachelor’s degree in Chemical, Biochemical, Mechanical, or related Engineering; advanced degree preferredstrong communicationcross-functional collaborationmentorshipAutoCADMS OfficeSAP