Principal Process Engineer

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🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🔴 Experte

👷🏻‍♀️ Ingenieur

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Syner-G BioPharma Group

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

🏭 Fertigung

Healthcare • Consulting • Manufacturing

Die Syner-G BioPharma Group ist der weltweit führende Anbieter von Lösungen in den Bereichen Chemie, Herstellung und Kontrolle (CMC), regulatorische Angelegenheiten und medizinisches Schreiben für den Biopharma-Sektor. Sie bieten umfassende Dienstleistungen, die Kunden durch die Komplexitäten der pharmazeutischen Entwicklung, regulatorische Einreichungen und Qualitätssicherung navigieren, um qualitativ hochwertige Ergebnisse sicherzustellen. Mit einem interdisziplinären Team integriert Syner-G wissenschaftliche, ingenieurtechnische und regulatorische Expertise, um die Arzneimittelentwicklung von der Vor-IND-Phase bis zur Phase nach der Zulassung zu unterstützen, was zeitgerechte Einreichungen und die Einhaltung der Patientensicherheit ermöglicht.

Beschreibung

• Lead enterprise-level process development, optimization, and scale-up initiatives across upstream, downstream, or formulation operations • Serve as senior technical authority for process automation strategy, advanced control methodologies, digital transformation, and next-generation technology integration • Develop, review, and approve PFDs, P&IDs, engineering studies, equipment specifications, and process descriptions • Conduct process modeling, statistical analysis, and system-wide assessments • Lead commissioning, qualification, and startup of major process systems, automated equipment, and integrated manufacturing platforms • Partner with automation, engineering, operations, and digital teams on monitoring tools, predictive analytics, and data-driven process control solutions • Troubleshoot critical process deviations, equipment failures, and automation issues • Lead multi-site technology transfer activities across development, clinical, and commercial environments • Oversee vendors and manage equipment upgrades, process redesigns, and automation projects • Drive continuous improvement in yield, throughput, cost efficiency, and process robustness • Mentor, coach, and develop engineering staff and contribute to succession planning • Advise internal leadership and client executives on process strategy, risk mitigation, and technical planning • Influence engineering standards, best practices, and technology roadmaps

🎯 Anforderungen

• 18+ years of process engineering experience in biotech, pharmaceutical, or advanced manufacturing environments • Extensive experience with automated process equipment, including bioreactors, chromatography systems, filtration skids, or formulation systems • Deep expertise with DeltaV, Rockwell, Siemens, and SCADA/PLC systems • Demonstrated leadership in process development, scale-up, equipment integration, and process optimization across multiple programs or sites • Ability to lead cross-functional teams, manage complex technical programs, and mentor engineering staff • Experience shaping process strategy, influencing technical direction, and contributing to long-term operational planning • Expert-level understanding of process engineering fundamentals, mass/energy balances, process control, and equipment design • Ability to develop, interpret, and approve P&IDs, engineering drawings, and automation logic • Advanced data analysis and modeling capabilities using engineering and statistical tools • Excellent communication, leadership, and program management skills • Ability to manage multiple high-priority initiatives in a fast-paced, technically demanding environment • Regular computer keyboard and mouse use, reaching, talking, listening, walking, and sitting • Ability to lift and carry objects weighing up to 25 pounds • Ability to occasionally stand, stoop, or kneel • Close vision and ability to adjust focus • Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time

🏖️ Vorteile

• Market competitive base salary • Annual incentive plan • Robust benefit offerings • Ongoing recognition and career development opportunities • Generous flexible paid time off program • Company-paid holidays • Flexible working hours • Fully remote work options for most positions • Ability to work “almost anywhere” • Equal Employment Opportunity and Affirmative Action employer