Principal Process Engineer

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🕒 il y a 1 jour

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🔴 Expert

👷🏻‍♀️ Ingénieur

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Syner-G BioPharma Group

Site WebLinkedInTous les Emplois

201 - 500 employés

🏥 Santé

💼 Conseil

🏭 Fabrication

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group est le leader mondial dans la fourniture de solutions en chimie, fabrication et contrôles (CMC), affaires réglementaires, et rédaction médicale pour le secteur biopharmaceutique. Ils offrent des services complets qui guident les clients à travers les complexités du développement pharmaceutique, des soumissions réglementaires, et de la conformité qualité, assurant des résultats de haute qualité. Avec une équipe multidisciplinaire, Syner-G intègre la science, l'ingénierie et l'expertise réglementaire pour soutenir le développement de médicaments depuis les phases pré-IND jusqu'à la post-approbation, permettant des soumissions en temps opportun et une adhésion à la sécurité des patients.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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