CSV Engineer — GMP Validation & CQV Specialist

Katalyst CRO

Grand Forks (ND)

On-site

USD 90,000 - 130,000

Full time

48 hours ago

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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.