Sr. Validation Engineer II
Core
Lead execution of equipment, systems, facilities, and utilities qualification (CD, DQ, IQ, OQ, PQ, CV) in a regulated pharmaceutical manufacturing environment.
Role type
Senior Validation Engineer
Builds
Qualified and validated manufacturing equipment, computerized systems, facilities, and utilities
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Commissioning and Qualification (C&Q), Change Control Management, Project Management, Regulatory Compliance (cGMP), Technical Troubleshooting, Data Analysis, Cross-functional Collaboration, Inspection Readiness, CAPA Management, Gowning/Safety Protocols
Preferred skills
LIMS, MES, ERP, SCADA, DCS (Delta V)
Technologies
LIMS, MES, ERP, SCADA, DCS, Delta V, Microsoft Word, Microsoft Excel
Responsibilities
Lead execution of Cycle Development, Design Qualification, Commissioning, and Performance Qualification activities; Act as project manager for validation deliverables ensuring timeline and budget adherence; Supervise and manage contractors or consultants; Participate in change control review board; Track and trend activities and report on issues; Serve as technical subject matter expert on cross-functional teams; Troubleshoot and direct resolution of validation issues; Maintain inspection readiness and act as SME in Health Authority inspections; Review and approve commissioning documents; Generate, execute, and manage detailed project plans for validation activities; Support capital project validation activities; Provide validation key performance indicators data; Coordinate sample collection and data retrieval; Perform equipment and system re-qualification; Solve technical problems while maintaining safety and quality standards; Support EHS programs and own CAPA records.
Seniority
Senior, hands-on IC
