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# CSV Engineer / Validation Engineer

- **Company:** Verista, Inc.
- **Location:** Kalamazoo, MI, United States
- **Experience:** Experienced
- **Salary:** $65,000.0 - $90,000.0
- **Contract:** Permanent contract
- **Skills:** Data Integrity, Supervisory Control and Data Acquisition (SCADA), Software Requirements Analysis, System Testing, Iq/oq/pq, Information Technology, GXP
- **Published:** May 22, 2026
- **Apply:** https://www.careerjet.com/jobad/us070dfb12fadd6222cef60f2fe52d3475

## About the Role

* Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical field
 * 3+ years of hands-on Computer System Validation (CSV) experience in a regulated pharmaceutical or biotechnology environment, supporting MES and/or Electronic Batch Record (EBR) systems
 * Working knowledge of cGMP regulations, including 21 CFR Part 11 and EU Annex 11, and application of GAMP 5 principles across the system lifecycle
 * Experience supporting validation documentation and testing activities (URS, FDS, risk assessments, IQ/OQ/PQ) and managing deviations and change controls
 * Ability to collaborate effectively with cross-functional teams (Operations, Quality, Engineering, IT, Automation) and support system interfaces with PLC/SCADA-controlled equipment
 * Ability to travel/be on-site up to 25% of the time in Kalamazoo, MI. This role can be 75% remote.

## Description

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:

 * We empower and support our colleagues
 * We commit to client success at every turn
 * We have the courage to do the right thing
 * We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
 * We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Validation Engineer Responsibilities:

 * Execute Computer System Validation activities for Electronic Batch Record (EBR) systems supporting aseptic fill operations in compliance with cGMP, 21 CFR Part 11, and EU Annex 11
 * Support development and review of validation deliverables including URS, FDS, risk assessments, and validation plans in alignment with GAMP 5 principles
 * Collaborate with Operations, Quality, Engineering, IT, and Automation teams to define system requirements, intended use, and validation scope
 * Participate in execution and documentation of validation testing (IQ, OQ, PQ), including deviation tracking and resolution support
 * Support validation of interfaces between PLC/SCADA systems and MES/EBR platforms to ensure data integrity and accurate batch execution
 * Maintain organized, inspection-ready validation documentation and support change control and periodic review activities for validated EBR systems


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