Sr. Team Leader - Calibration
Core
Lead calibration, qualification, and maintenance activities for engineering instruments and systems to ensure equipment reliability, regulatory compliance, and operational excellence in a pharmaceutical manufacturing environment.
Role type
Senior Team Leader - Calibration & Reliability Engineering
Builds
Reliable utility systems, buildings, and production/non-production equipment for medicine delivery
Domain
Pharmaceutical manufacturing / Regulatory compliance (cGMP)
Required skills
Calibration methodologies, Instrumentation lifecycle management, Regulatory compliance (cGMP, GDP, 21 CFR Part 11), FAT/SAT/IQ/OQ/PQ/PV protocols, Root cause analysis, CAPA implementation, Vendor management, Budget management, Team leadership
Preferred skills
Generative AI tools (ChatGPT, Copilot), Risk management, Ethical AI use
Technologies
EAMS, Calibration management software, Field instruments, Sensors, Automation systems
Responsibilities
Plan and execute calibration and qualification activities, Review and approve qualification documents, Maintain instrument master data, Lead change controls and investigations, Support internal and regulatory audits, Coordinate calibration activities with vendors, Monitor equipment performance and implement corrective actions, Lead troubleshooting and reliability initiatives, Coach and develop team members, Manage departmental budgets, Ensure EHS compliance
Seniority
Senior, hands-on IC with team leadership
