Principal/Senior Principal Validation Engineer
Core
Establishing and executing lifecycle validation strategies (IQ/OQ/PQ/PPQ) for high-speed pre-filled syringe assembly, labeling, and packaging lines in a new greenfield facility.
Role type
Principal/Senior Principal Validation Engineer
Builds
Validated manufacturing assets for drug-device combination products (autoinjectors, pen lines) and packaging lines.
Domain
Pharmaceutical manufacturing / Biotechnology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation strategy design, IQ/OQ/PQ/PPQ execution, Validation Master Plan ownership, Change control management, Deviation management, Risk management, Regulatory compliance (cGMP/FDA/ISO), Project management, Technical design review, SOP authoring, Cross-functional collaboration, Continuous improvement, Industrial engineering
Preferred skills
Greenfield facility launch experience, Technology transfer leadership, Audit presentation, Contract organization management
Technologies
None explicitly listed beyond regulatory standards (FDA 21 CFR, ISO 11607)
Responsibilities
Define and maintain Validation Master Plan for assembly and packaging lines; Author and execute PQ/PPQ protocols and reports; Lead validation for NPI, capital expansions, and technology transfers; Provide technical leadership and mentorship to junior engineers; Review and approve change controls and engineering specifications; Lead presentation of validation program during audits and inspections.
Seniority
Principal/Senior Principal, hands-on IC with strategic oversight
