Team Member Qualifications
Core
Execute equipment and system qualification protocols (IQ, OQ, PQ) and support regulatory readiness in pharmaceutical manufacturing.
Role type
Senior IC Qualification & Validation Specialist
Builds
Qualified pharmaceutical equipment, clean utilities, and process systems
Domain
Pharmaceutical Manufacturing / Quality Assurance
Required skills
Qualification Protocols (IQ/OQ/PQ), cGMP compliance, Risk Assessments, Vendor Audits, SOP Development, Change Control, Data Analysis, Preventive Maintenance, Regulatory Compliance, Calibration
Preferred skills
Computer System Validation, Greenfield/Brownfield plant setup, Audit response, Lean Methodologies
Technologies
eVal, URS, DQ
Responsibilities
Execute qualification protocols (IQ, OQ, PQ) and coordinate with vendors and cross-functional teams; Compile qualification documents, prepare risk assessments, SOPs, validation programs, and master plans; Execute equipment requalification and update qualification schedules; Assist in audit responses and coordinate CAPA, incidents, and deviations; Prepare master documents and coordinate risk assessments for equipment/systems; Assess safety risks and drive implementation of safe procedures; Support digital system implementation and coordinate URS, DQ, and quantitative risk assessments.
Seniority
Senior, hands-on IC
