Sr. Equipment Validation Engineer

Sr. Equipment Validation Engineer – Katalyst CRO

• Monitor due dates for lab instrument reviews and coordinate with stakeholders.
• Execute SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+ data integrity.
• Perform gap analyses, remediation plans, and efficiency enhancements for lab operations.
• Report metrics on validation status, closures, and compliance to internal teams.
• Coordinate system changes with QA/equipment owners, author validation protocols, and complete change documentation.
• Track periodic instrument reviews using schedulers, generate RTMs/VSRs, and finalize compliance artifacts.
• Lead team task assignments, deliver validation training, and drive multi-site demand planning for GMP upkeep.

• Minimum 8 years in GxP/analytical lab settings with hands‑on validation of GMP instruments, including HPLC, UV‑VIS, FTIR, NMR, Polarimeter, XRD, Kaye Validators, and LIMS/Empower3 systems.
• Proven expertise in IQ/OQ/PQ protocols, RTM/VSR generation, SOP adherence, and 21 CFR Part 11/GAMP5 compliance.
• Experience leading offshore‑onsite validation teams, assigning tasks, providing technical training, and managing multi‑site equipment qualifications.
• Strong skills in change control (Service Now/Remedy), CAPA/deviation handling, gap analyses, and process improvements for lab efficiency.
• Ability to review/approve GMP deliverables (VMPs, test scripts, audit trails) in team environments with stakeholder collaboration and metrics reporting.
• Administer lab systems via ticketing (helpdesk, user access) while executing IQ/OQ/PQ for instruments such as HPLC.
• Collaborate with analysts/owners to troubleshoot, validate, and resolve instrument issues per SOPs (onsite/remote).

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