Validation Lead
Katalyst CRO
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, including IQ/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. 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, including IQ/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. Required Skills 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. #J-18808-Ljbffr
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$127.4k - $236.6k
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$105.65k - $200.34k
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$122.44k - $232.19k
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...expected and able to complete the following responsibilities:Own or lead verification of complex flows at subsystem, IP or block level.... ...the successful candidate’s citizenship will be verified with a valid passport. Lawful permanent residents, refugees, and asylees may...Ongoing contractPermanent employmentInternshipWork at officeLocal areaWorldwide3 days per week$122.44k - $232.19k
...pioneered event-driven, sparse, and massively parallel neuro-inspired processing, fueling over 100 peer-reviewed publications that validate the promise of this novel approach.Now, we're entering an exciting new chapter: transforming these breakthroughs into real-world...Full timeLocal areaImmediate startShift work$257.74k - $363.86k
...architecture for the end-to-end telemetry platform, from field and validation data collection through the data lake to insights delivery.... ...models that track platform, ingredient, and OEM quality health. Lead the development of in-field and app telemetry solutions that is...Local areaImmediate startShift work$168k - $264.5k
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$133.2k - $183k
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