Katalyst CRO
CSV Engineer
⭐ - Featured Role | Apply direct with Data Freelance Hub
This role is for a CSV Engineer, offering a remote contract for 6-12 months at a competitive pay rate. Requires 7-10 years in CSV/Validation within Pharma/Biotech/Medical Devices, expertise in GxP, and strong leadership in regulated environments.
🌎 - Country
United States
💱 - Currency
$ USD
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💰 - Day rate
Unknown
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🗓️ - Date
May 7, 2026
🕒 - Duration
Unknown
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🏝️ - Location
Remote
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📄 - Contract
Unknown
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🔒 - Security
Unknown
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📍 - Location detailed
Raritan, NJ
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🧠 - Skills detailed
#Alation #Data Migration #Scala #Cloud #Migration #Leadership #UAT (User Acceptance Testing) #Documentation #Compliance
Role description
Roles & Responsibilities
• Lead end-to-end CSV activities (inventory � assessment � remediation � disposition)
• Support business separation for large GxP systems
• Define & implement risk-based validation strategies
• Review & approve test plans, UAT scripts, validation documents
• Ensure compliance with regulatory & quality standards
• Provide guidance, escalation & leadership to validation teams
• Collaborate with global & remote teams
Education & Experience :
• 710 years in CSV / Validation roles
• Experience in Pharma / Biotech / Medical Devices industry
• Proven experience in regulated environments (FDA/GxP)
• Strong expertise in CSV (Computer System Validation) in GxP environments
• Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation)
• Hands-on in Acquisitions / Divestitures / Business Separation projects
• Deep understanding of FDA regulations & GxP standards
• Experience with Risk-based validation approach
• Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs)
• Experience in UAT, Traceability Matrix & QA methodologies
• Ability to lead teams & manage multiple projects
Roles & Responsibilities
• Lead end-to-end CSV activities (inventory � assessment � remediation � disposition)
• Support business separation for large GxP systems
• Define & implement risk-based validation strategies
• Review & approve test plans, UAT scripts, validation documents
• Ensure compliance with regulatory & quality standards
• Provide guidance, escalation & leadership to validation teams
• Collaborate with global & remote teams
Education & Experience :
• 710 years in CSV / Validation roles
• Experience in Pharma / Biotech / Medical Devices industry
• Proven experience in regulated environments (FDA/GxP)
• Strong expertise in CSV (Computer System Validation) in GxP environments
• Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation)
• Hands-on in Acquisitions / Divestitures / Business Separation projects
• Deep understanding of FDA regulations & GxP standards
• Experience with Risk-based validation approach
• Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs)
• Experience in UAT, Traceability Matrix & QA methodologies
• Ability to lead teams & manage multiple projects
