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Katalyst

Katalyst

66 jobs near Columbus, OH

Katalyst

CSV Engineer

Columbus, OH · On-site

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 ...

Katalyst

C&Q Engineer

New Albany, OH · On-site

This is not a validation role - we are looking for a true C&Q professional with deep expertise in ... Perform hands-on equipment walkdowns, system verifications, and commissioning checks directly on ...

Katalyst

Mechanical Tool Designer

Delaware, OH · On-site

Bachelor's degree in mechanical engineering. Experience Range: * 5 -7 Years. Skills: * Design and develop manufacturing automation systems, including assembly automation, machine integration, and ...

Katalyst

Quality Manager

Alexandria, OH · On-site

This role focuses on aligning stakeholders, evaluating current quality processes and systems, and ... Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master ...

Experis

System Validation Engineer

Auburn Hills, MI

$28/hr

As a System Validation Engineer, you will be part of the Vehicle Engineering Department supporting propulsion system validation and diagnostics. Job Title: System Validation Engineer (Vehicle Triage ...

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

Katalyst CRO is a company focused on providing services in the life sciences sector, and they are ... This role is responsible for authoring and executing validation test scripts for regulated systems ...

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

Katalyst CRO is seeking an IT CSV Validation Engineer responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role ...

ATEM Corp

System Validation Engineer

Sunnyvale, CA · On-site

System Validation Engineer (Multimodal AI / Camera) Location: Sunnyvale, CA (Onsite) Exp: 5-12 years Must Haves: Image Quality validation, Camera hardware characterization, AI, system validation ...

Experis

Silicon System Validation Engineer

Sunnyvale, CA · On-site

$50 - $53/hr

Silicon System Validation Engineer, Sunnyvale CA 6+ months Contract (Possibility of extension) Pay range: 50-53/hr on w2 As a Silicon System Validation Engineer , you will be part of the RL Silicon ...

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CSV Engineer

Katalyst

Columbus, OH • On-site

Full-time

Re-posted yesterday

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:
  • Author, 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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