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# CSV Engineer

- **Company:** PSC Biotech
- **Location:** Columbus, OH, United States
- **Experience:** Experienced
- **Contract:** Permanent contract
- **Skills:** Software Applications, Data Integrity, Electronic Signatures, Automation of Marketing, Data Streaming, System Testing, Computerised Systems, Information Technology, Industrial Software, GXP
- **Published:** June 11, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=0af96f571a062e4a

## About the Role

Do you have experience in Validation design?, * Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related discipline.

 * 3-6 years of experience in computerized system validation, automation systems, or manufacturing software support within a regulated industry (pharma, biotech, or medical device).
 * Working knowledge of cGMP requirements and validation frameworks (e.g., GAMP 5).
 * Familiarity with manufacturing systems such as automation platforms, control systems, and/or MES/OMS applications.
 * Experience with validation documentation, including protocol development, execution, and traceability.
 * Strong technical troubleshooting and analytical skills.
 * Excellent written and verbal communication skills, with the ability to collaborate across functional teams.
 * Must be authorized to work in the U.S.
 * No C2C at this time.

## Description

We are seeking a CSV Engineer to support computerized system validation activities within a regulated manufacturing environment. This individual will work closely with cross-functional teams to ensure automation and manufacturing systems are implemented, tested, and maintained in compliance with regulatory standards. The role will play a key part in supporting system lifecycle activities, with a strong emphasis on documentation, compliance, and data integrity.

 * Support the validation lifecycle for computerized systems, including development, review, and execution of validation deliverables.
 * Partner with Engineering, Quality, IT, and external vendors to ensure systems are implemented and maintained in alignment with regulatory and internal standards
 * Assist in the configuration, testing, and troubleshooting of automation and manufacturing-related software applications.
 * Evaluate system changes and support change control activities, including impact assessments and associated documentation updates.
 * Ensure systems meet data integrity and electronic records/electronic signature requirements (e.g., 21 CFR Part 11).
 * Support integration and data flow between manufacturing systems (e.g., equipment automation, MES/OMS platforms) to ensure reliable and accurate system performance.
 * Review and approve technical and validation documentation to ensure completeness, accuracy, and compliance with cGMP requirements.


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