Principal Process Engineer
Scorpion Therapeutics
The selected candidate for Principal Process Engineer (GMSAT Process Engineering) will lead the team responsible for design and development of new equipment, technologies, and single-use materials for the biomanufacturing network. Lead cross-functional evaluations of technologies to improve and optimize the biomanufacturing platform, develop support documentation for implantation into the global processing platform, and provide technical/operational support to Site MSAT and Manufacturing Operations. May provide person-in-plant support, assist with regulatory submissions, and support regulatory and site inspections. What You’ll Do: Develop strategies for design/development of new and existing technologies. Develop lifecycle and maintenance management program for GMP equipment/technologies. Support evaluation and approval of innovative technologies via project governance. Partner with stakeholders/vendors to improve efficiency and throughput. Develop global design documents (URS, software functional specs) and support validation CQV protocols. Collaborate on DCS design and PLC-to-DCS integration. Support utility/layout evaluations and associated CQV activities. Evaluate single-use technologies for data acquisition and suitability. Develop data/validation packages for GMP implementation with vendors. Create business processes, guidelines, SOPs, and training for equipment/technologies. Build maintenance & life cycle plans. Support Non-Conformance, CAPAs, and process impact evaluations. Who You Are: BS (engineering/sciences/life science engineering) +12 years; or MS +10 years in pharma/biotech/life sciences. SME in cell culture biopharmaceutical manufacturing (chromatography, filtration, viral clearance, formulation). Upstream cell culture/perfusion processing knowledge. Experience with GMP single-use instrumentation/assemblies; leachables & extractables knowledge. Leading technology implementation/validation for clinical/commercial readiness. Facility fit assessments and process validation experience. Independent and cross-functional leadership; quality and attention to detail. Ability to organize/analyze/present data to senior leadership. Additional Preferred Qualifications: Continuous process monitoring/manufacturing strategy oversight. DeltaV automation experience. Experience leading CQV plans/protocols; lead cross-functional projects. Application: Take the leap and apply today. #J-18808-Ljbffr Scorpion Therapeutics
$134k - $154.1k
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