Validation Engineer (6-Month Backfill Contract) – 100% Onsite Location: Onsite (no hybrid/remote option) Duration: 6-Month Contract Experience Required: Minimum 5 years Start: ASAPAbout the RoleWe are seeking an experienced Validation Engineer to support a 6‑month backfill within a highly regulated pharmaceutical/medical device/diagnostics environment. This role requires full onsite presence and hands‑on execution of validation activities across facilities, utilities, equipment, processes and automation systems.Key ResponsibilitiesLead, coordinate, and actively participate in the validation of equipment, facilities, utilities, processes, and software in accordance with company policies and global regulatory standards (FDA, EU cGMP, GAMP).Perform risk‑based qualification activities, including Equipment Risk Assessments and development of Critical Elements Test Plans.Execute Commissioning & Qualification tasks, including IQ, OQ, and PQ for facilities, utilities and equipment.Support and execute PPQ activities.Generate and maintain validation documentation to cGMP standards, including:Validation PlansProtocols (IQ/OQ/PQ)Final ReportsReview and approve validation protocols, deviations, reports, and supporting documentation.Ensure all validation activities comply with internal procedures and regulatory requirements.Collaborate with cross‑functional teams to resolve validation issues and maintain compliance.Required Experience & Skills✔ Minimum 5 years industry experience in pharmaceuticals, medical devices, or diagnostics✔ Strong expertise in:Risk‑based qualificationCommissioning & Qualification (C&Q)IQ / OQ / PQ executionPPQ (Process Performance Qualification)Automation validation✔ Hands‑on experience generating and executing validation protocols✔ Strong understanding of FDA, EU cGMP, GAMP and validation best practices✔ Ability to write clear, compliant validation documentation✔ Excellent coordination, communication, and cross‑functional collaboration skillsIdeal CandidateYou are a detail‑oriented validation professional who thrives in regulated environments, brings strong technical judgement, and can deliver high‑quality validation outputs independently while working fully onsite.
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