CSV LIMS Lead

CSV LIMS Lead (Thermo Fisher SampleManager)Location: On-site (New Jersey)Engagement Status: ContractKey ResponsibilitiesLead end-to-end implementation and configuration of Thermo Fisher SampleManager LIMSTranslate laboratory and shop-floor workflows into compliant digital processesManage LIMS integrations with laboratory systems and instrumentsDrive CSV activities, including URS authoring and IQ/OQ/PQ executionEnsure compliance with GMP / GxP regulationsSupport go-live, on-site deployment, and hypercareCollaborate with Quality, IT, and Lab stakeholders to ensure user adoptionRequirementsHard Skills / Technical ExpertiseHands-on experience with Thermo Fisher SampleManager LIMSStrong expertise in Computer System Validation (CSV) within GMP / GxP environmentsProven experience authoring URS and executing IQ/OQ/PQExperience integrating LIMS with laboratory instruments and enterprise systemsSolid understanding of regulated laboratory and manufacturing processesExperience delivering or validating enterprise-scale IT applicationsSoft Skills / Professional CompetenciesStrong stakeholder management skills, able to work across Quality, IT, and Lab OperationsClear and confident communication skills, both technical and non-technicalAbility to translate complex laboratory workflows into structured system requirementsHighly detail-oriented, quality-driven, and compliance-focusedProactive, hands-on approach during critical project phases and go-liveStrong problem-solving and decision-making capabilitiesComfortable working in fast-paced, regulated project environmentsEducationBachelor’s degree in a STEM-related discipline (Science, Engineering, IT, or similar)📩 Interested candidates are encouraged to apply directly or email:alexander.sysum@msipharma.com***NO BENCH RECRUITERS PLEASE***