CSV Engineer

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

Job 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.

Qualifications

• Approximately 510 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.