Senior Manager Instrumentation and Maintenance
Core
Oversee the Maintenance and Instrumentation team to support 24/7 operations of a biotech drug substance manufacturing plant, ensuring equipment reliability and cGMP compliance.
Role type
Senior Manager Instrumentation and Maintenance
Builds
Drug substance manufacturing operations using single-use and stainless steel technologies
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (plant operations & maintenance)
Required skills
Engineering management, Preventive Maintenance strategy, Calibration program management, cGMP compliance, Safety management, Budgeting, Team leadership, CMMS implementation, Continuous improvement, Capital project execution
Preferred skills
Biotechnology/pharmaceutical industry experience, Regulatory compliance experience, Mentorship, Technical writing, Cross-functional collaboration
Technologies
CMMS, Single-use technologies, Stainless steel equipment
Responsibilities
Lead and develop a diverse team of maintenance and instrumentation technicians; Develop and implement long-term technical support strategies; Ensure alignment of maintenance and calibration programs with cGMP and safety regulations; Manage maintenance budgets and forecasting; Execute complex facilities and maintenance projects; Ensure site readiness for internal and external audits; Collaborate with Manufacturing, Quality, and EHS groups.
Seniority
Senior Manager, hands-on leadership