Manager, Equipment Commissioning & Qualification (ECQ)
Core
Ensures the operation of QC laboratories, commercial manufacturing, and support services equipment, utilities, and facilities at a multi-product site by coordinating complex projects and managing project teams.
Role type
Manager, Equipment Commissioning & Qualification (ECQ)
Builds
Commissioning, Qualification, and Validation (CQV) activities for equipment, facilities, utilities, and laboratory computerized systems
Domain
Pharmaceutical manufacturing and laboratory operations
Required skills
Project management, cGMP/GXP/GAMP regulatory knowledge, System Lifecycle management, SOP/WP development, Risk assessment, Change strategy, CAPA management, Team leadership, Schedule development, Cost control
Preferred skills
BS in Engineering or science, 7+ years pharmaceutical validation experience, 3.5+ years people/project management, Instrumentation background, Audit interaction experience, CMMS proficiency
Technologies
Microsoft Office Suite, CMMS, Validation systems, Task-specific software
Responsibilities
Leads individual contractors or project teams; Coordinates project execution and resource allocation for CQV activities; Oversees development and review of SOPs, WPs, and validation deliverables; Ensures compliance with local, site, and global BMS policies; Acts as SME in internal and regulatory audits; Manages workload and training of project team members; Provides technical support for equipment and system qualification issues.
Seniority
Manager, hands-on IC with people management