CSV Engineer

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

Job summary

Katalyst CRO in Grand Forks, ND is seeking experienced CSV Engineers to provide onsite validation support in a regulated biopharmaceutical manufacturing environment. The role centers on Computer System Validation with equipment qualification and broader CQV activities as priorities.

You will support validation documentation and execution, assess computerized systems against GMP requirements, execute approved validation protocols, document results, investigate discrepancies, and collaborate with

Qualifications

• Experience in validating GMP computerized systems and CSV processes.
• Understanding of CSV lifecycle: planning, requirements, risk assessment, testing, traceability, documentation.
• Ability to execute validation protocols and document results clearly.

Responsibilities

• Provide onsite validation support for a regulated biopharma environment.
• Focus on Computer System Validation with equipment qualification and CQV activities as priorities.
• Support validation documentation, testing, and discrepancy investigations; collaborate across Quality, Engineering, Manufacturing, Automation, IT, and system owners.
• Work independently across multiple validation workstreams in a fast-moving project environment.

Skills

CSV validation

GMP knowledge

CQV experience

Cross-functional collaboration

Education

Bachelor’s in Life Sciences or Engineering

Tools

CQV tools

Validation lifecycle tools

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.

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.