Senior CSV Engineer – GMP Validation & CQV Expert

Katalyst CRO; Grand Forks (ND); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO seeks experienced CSV Engineers to provide onsite validation support in a regulated biopharmaceutical manufacturing environment. The role focuses primarily on Computer System Validation while also supporting equipment qualification and CQV activities as project priorities require.

Responsibilities include validating computerized systems against GMP requirements, executing approved validation protocols, documenting test results, investigating discrepancies, and working

Qualifications

• Extensive experience in CSV in GMP environments.
• Strong exposure to validation lifecycle elements: planning, requirements, testing, and documentation.
• Ability to work cross-functionally with Quality, Engineering, Manufacturing, Automation, IT, and system owners.

Responsibilities

• Provide onsite CSV validation support in a regulated biopharma setting.
• Support equipment qualification and broader CQV activities as priorities require.
• Validate computerized systems against GMP requirements and execute approved protocols.
• Document test results, investigate discrepancies, and maintain validation artifacts.
• Collaborate across Engineering, Quality, Manufacturing, Automation, IT, and system owners.

Skills

CSV validation expertise

GMP CSV experience

Validation lifecycle knowledge

Cross-functional collaboration

Independent in fast-paced projects

Job description

Katalyst CRO seeks experienced CSV Engineers to provide onsite validation support in a regulated biopharmaceutical manufacturing environment. The role focuses primarily on Computer System Validation while also supporting equipment qualification and CQV activities as project priorities require.

Responsibilities include validating computerized systems against GMP requirements, executing approved validation protocols, documenting test results, investigating discrepancies, and working