Quality Facilities & Equipment Validations Specialist
Core
Technical subject matter expert for facility, equipment, temperature mapping, and shipping validation programs in a highly regulated pharmacy environment.
Role type
Quality Facilities & Equipment Validations Specialist
Builds
Inspection-ready validation programs supporting regulatory compliance and product quality
Domain
Pharmaceutical manufacturing / GMP / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification (IQ/OQ/PQ), validation lifecycle management, protocol development, regulatory documentation, project management, technical writing, gap analysis, corrective action coordination, stakeholder collaboration, training delivery
Preferred skills
Master Validation Plan management, temperature mapping, facility qualification, shipping validation, regulatory inspection support, USP <797> & <800> knowledge, external vendor management
Technologies
IQ/OQ/PQ frameworks, validation software, regulatory databases
Responsibilities
Own and maintain the Master Validation Plan; Manage equipment qualification and requalification programs; Oversee temperature mapping, facility certification, and shipping validation; Develop and maintain validation protocols and reports; Identify validation gaps and coordinate corrective actions; Track requalification and certification requirements; Partner with cross-functional teams on validation initiatives; Support regulatory inspections and audits; Provide validation-related training and technical guidance; Support validation of new equipment, systems, processes, and facilities throughout their lifecycle; Build internal validation capabilities and expertise
Seniority
Mid-Senior, hands-on IC
