Equipment Management Associate
Core
Oversee the full GMP equipment lifecycle (onboarding, qualification, maintenance, calibration, retirement) for laboratory and manufacturing assets in a biopharmaceutical environment.
Role type
Equipment Management Associate (GMP)
Builds
GMP-compliant equipment lifecycle management supporting BioPharm CMC operations
Domain
Biopharmaceuticals / Life Sciences / GMP Compliance
Required skills
GMP regulations, equipment lifecycle management, deviation/CAPA/change control management, vendor coordination, documentation management, stakeholder management
Preferred skills
IQ/OQ/PQ validation, electronic quality/maintenance systems, System Lifecycle (SLC) processes, audit support
Technologies
Electronic quality systems, Electronic maintenance systems
Responsibilities
Oversee equipment lifecycle from onboarding to retirement; Coordinate with internal stakeholders and external vendors; Serve as Subject Matter Expert for equipment issues; Ensure compliance with GMP and internal procedures; Manage deviations, CAPAs, and change controls; Maintain audit-ready equipment records; Monitor equipment status and resolve downtime; Support procurement activities.
Seniority
Mid-level, hands-on IC