Manufacturing Sciences Technology (MSAT) Process Engineer, 2nd 3rd Shifts

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� Description

• • Drive the continuous improvement of Orca Bio’s life-saving cell-therapy manufacturing processes during 2nd (Mon–Fri 3 pm–11:30 pm) or 3rd shift (Mon–Thu 9 pm–7:30 am) in our 100,000 ft² state-of-the-art GMP facility in Sacramento.
• • Own the end-to-end life-cycle management of commercial cell-therapy products: monitor real-time process performance, generate trend reports, and implement corrective and preventive actions (CAPA) that directly safeguard patient safety and product purity.
• • Serve as the on-the-floor technical authority for manufacturing deviations—rapidly troubleshoot equipment alarms, raw-material issues, and in-process excursions; perform rigorous root-cause analysis using DMAIC, fishbone diagrams, and statistical tools to isolate true cause and prevent recurrence.
• • Lead cross-functional teams to design, validate, and execute process-improvement projects—ranging from minor electronic-batch-record revisions to major scale-up modifications—that increase yield, reduce cost-of-goods, and shorten vein-to-vein time for patients battling blood cancers.
• • Author and own critical GMP documentation: change-control packages, validation protocols & reports, technical investigations, risk assessments, and SOP revisions; ensure all activities comply with FDA 21 CFR Part 211, EudraLex Annex 1, and company quality systems.
• • Partner with Manufacturing, Quality, Facilities, and Automation to commission new isolators, bioreactors, and in-line analytics; develop user-requirement specifications, FAT/SAT protocols, and qualification documentation that meet global regulatory expectations.
• • Establish and maintain real-time process-monitoring dashboards (using PI, JMP, or equivalent) that track CPPs and CQAs; proactively flag drift and trigger investigations before specification limits are breached.
• • Mentor junior engineers and production associates on scientific principles, GMP behaviors, and shift hand-off best practices, cultivating a culture of data-driven decision making and patient-centric urgency.
• • Participate in regulatory inspections and PAI readiness activities; present technical data and defend process robustness to FDA, EMA, and notified-body reviewers.
• • Champion lean/6-sigma initiatives—Kaizen events, 5S, SMED, OEE improvement—that eliminate waste, reduce ergonomic risk, and elevate right-first-time rates above 95 %.
• • Contribute to tech-transfer activities for next-generation high-precision cell-therapy candidates moving from clinical to commercial scale, ensuring seamless knowledge exchange and risk mitigation.
• • Maintain strict adherence to cleanroom gowning, aseptic technique, and safety protocols; model Orca Bio’s core values of passion, courage, and integrity in every interaction.