Senior Engineer (NPI & Glam)
Core
Lead equipment readiness for New Product Introduction (NPI), GLAM, and Site Projects in biopharmaceutical manufacturing facilities, serving as a technical project lead and system owner for process equipment.
Role type
Senior Process Engineer (NPI & GLAM)
Builds
Biotechnology/API Manufacturing facility equipment readiness and operational capabilities
Domain
Biopharmaceuticals / API Manufacturing / Process Engineering
Deliverable
physical/clinical work
Required skills
Process equipment validation (IQ/OQ/PQ), FAT/SAT/PSSR, system design, project management, stakeholder management, team leadership, GMP compliance, equipment reliability optimization
Preferred skills
Big data analysis, predictive monitoring, continuous improvement methodologies, cross-functional collaboration
Technologies
Big data analysis tools, automation checkouts, process control systems
Responsibilities
Lead equipment readiness initiatives for NPI, GLAM, and Site Projects; Perform assessments for equipment during new product introduction and qualifications; Coach and mentor system owners and subject matter experts; Represent Process Engineering team in design and engineering projects; Participate in commissioning and qualification activities; Benchmark equipment performance and drive reliability improvements
Seniority
Senior, hands-on IC with team leadership