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 cGMP compliance and equipment reliability.
Role type
Senior Manager, Facilities & Engineering (Instrumentation and Maintenance)
Builds
Drug substance manufacturing operations using single-use and stainless steel technologies
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Maintenance management, Instrumentation, cGMP compliance, Team leadership, Budgeting, Strategic planning, Safety management, Continuous improvement, System validation, Resource allocation
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 strategies and budgets; Ensure preventive maintenance and calibration programs align with cGMP and safety regulations; Support 24/7 plant operations and readiness for audits; Lead continuous improvement initiatives for safety, reliability, and efficiency; Collaborate with Manufacturing, Quality, and Engineering groups; Manage capital project execution and KPIs.
Seniority
Senior, hands-on IC with management responsibilities