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# CSV Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Boston, MA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Data Integrity, System Testing, Iq/oq/pq, Computerised Systems
- **Published:** August 21, 2026
- **Apply:** https://www.dice.com/job-detail/501540aa-eea8-4cda-ba8c-9e37c4afd81f

## About the Role

* Approximately 5-10 years of validation experience within pharmaceutical, biotechnology, biopharmaceutical, or another GMP-regulated environment.
 * Strong Computer System Validation experience.
 * Experience supporting validation of GMP computerized systems.
 * Working knowledge of the CSV lifecycle, including validation planning, requirements, risk assessment, testing/protocol execution, traceability, and validation documentation.
 * Understanding of data integrity and GMP expectations for computerized systems.
 * Equipment validation / CQV experience in addition to CSV.
 * Ability to execute established validation protocols and clearly document results.
 * Experience investigating and documenting validation discrepancies or execution issues.
 * Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
 * ValGensis is a plus.

## Description

* Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
 * The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require.
 * Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.
 * Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.


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