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Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities. Experience managing system integrations, data migration, and cross-functional project delivery. Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.
Strong stakeholder management, Agile/Scrum, and project coordination skills.
Excellent communication and documentation capabilities
KH
Katalyst Healthcares & Life Sciences
Senior Quality Control Engineer
Career Insights for Validation Engineer
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Based on Delaware data
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What they do
A Validation Engineer evaluates and maintains machinery and equipment used in manufacturing, and supervises workers that use and repair the machines.
$99,941 / year median in Delaware
-4% projected decline
Job Description
Roles & Responsibilities:
Lead implementation and integration activities for GMP QC systems. Coordinate system configuration, data migration, deployment, and stakeholder engagement. Conduct implementation kick-off sessions and drive project execution. Monitor project progress, risks, timelines, quality, and budget adherence. Prepare status reports and ensure transparent progress tracking. Support CSV/CSA and validation activities, includingIQ/OQ/PQ
execution and documentation. Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance. Ensure adherence to GxP, Data Integrity, and Roche validation standards. Support system acceptance, release readiness, and go-live activities.Requirements:
8+ years of experience in pharmaceutical, biotech, or regulated GMP environments. Strong experience with QC/Laboratory systems implementation and validation. Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities. Experience managing system integrations, data migration, and cross-functional project delivery. Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.
Strong stakeholder management, Agile/Scrum, and project coordination skills.
Excellent communication and documentation capabilities