CSV Engineer Jobs in Pennsylvania

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CSV Engineer

Sanofi U.S.

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Swiftwater, Pennsylvania, USA

Full-time

Job Title: CSV Engineer Location: Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our Team/ Overview Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improv
Posted 60+ days ago | Updated 8 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 13 days ago | Updated 8 hours ago

Sr. CSV Engineer

Katalyst Healthcares and Lifesciences

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Philadelphia, Pennsylvania, USA

Full-time

Roles & Responsibilities: Lab CSV consultant needed. Working on standard lab equipment systems, temp monitoring systems will be the first but will also include HPLC, and various other lab equipment. helping define a program and plan for validation. Work cross functionally with decision manager for writing SOPS and procedures, defining how to contribute to execution. There is a current team in place but they are scientists and not CSV experts so this person should really be 10+ years of e
Posted 17 days ago | Updated 8 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana