Validation Specialist
Core
Provide validation support and oversight for new processes, equipment, and commercial drug products at a large-scale oral dose manufacturing facility.
Role type
Validation Specialist (Pharmaceutical Manufacturing)
Builds
Validated manufacturing processes, equipment systems, and drug products for commercialization
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP guidelines knowledge, validation protocol drafting, risk assessment, deviation investigation, CAPA management, scientific writing, Microsoft Office proficiency
Preferred skills
Bachelor's degree in life sciences, TrackWise system knowledge, EDMS system knowledge, customer audit support experience
Technologies
TrackWise, EDMS, Microsoft Word, Microsoft PowerPoint, Microsoft Excel
Responsibilities
Draft and approve validation protocols and reports for computerized systems, automated equipment, facilities, and processes; Execute approved validation protocols and coordinate with engineering and production; Review and approve site Annual Product reviews; Assist in NPIx gate reviews; Participate in customer audits and respond to observations; Investigate manufacturing deviations; Address process and facility change controls and CAPAs.
Seniority
Mid-level, hands-on IC
