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Director Computer System Validation Csv Jobs in Ohio

RESILIENCE

CSV Engineer III

West Chester, OH · On-site

May oversee and direct the validation activities of others within assigned projects. Experience ... Hands-on experience with automation and computer system validation (CSV). * Working knowledge of ...

Resilience

CSV Engineer III

West Chester, OH · On-site

May oversee and direct the validation activities of others within assigned projects. Experience ... Hands-on experience with automation and computer system validation (CSV). * Working knowledge of ...

RESILIENCE

CSV Engineer III

West Chester, OH

May oversee and direct the validation activities of others within assigned projects. Experience ... Hands-on experience with automation and computer system validation (CSV). * Working knowledge of ...

ATS Automation

Automation Engineer

Lewis Center, OH

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT ... Direct experience working in regulated environments (GMP, OSHA, EPA) * Fluent in English with ...

Inteldot

Automation Engineer

New Albany, OH · On-site

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT ... Direct experience working in regulated environments (GMP, OSHA, EPA) * Willingness to travel ...

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Infographic showing various Director Computer System Validation Csv job openings in Ohio as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 20% Part Time, and 2% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

CSV Engineer

Katalyst Healthcares and Lifesciences

Columbus, OH • On-site

Other

Posted 2 days ago

New

Job description

Job Summary:
  • The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).
  • This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.
  • By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.
Roles & Responsibilities:
  • uthor, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
  • Support computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).
  • Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
  • Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
  • Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.
Education & Experience:
  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).
  • 5-7+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
  • Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
  • Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.
  • Strong technical writing skills and ability to execute protocols with minimal supervision.
  • Nice to have: BMRAM and analytical lab instruments experience.

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