Senior CSV Engineer for GMP Validation (Biopharma)

Katalyst CRO; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO seeks experienced CSV Engineers for on-site validation support in a regulated biopharmaceutical environment. The role centers on Computer System Validation while also supporting equipment qualification and broader CQV activities as priorities require.

Consultants will validate documentation and execute protocols, assess systems against GMP requirements, document results, investigate discrepancies, and work across Engineering, Quality, Manufacturing, Automation, IT, and system owners.

Qualifications

• Approximately 5–10 years of validation experience in GMP-regulated environments.
• Strong CSV validation experience and knowledge of GMP expectations.
• Experience validating GMP computerized systems and CQV activities.

Responsibilities

• Support validation documentation and execution activities on-site.
• Assess computerized systems against GMP requirements and execute validation protocols.
• Document test results and investigate discrepancies.
• Collaborate cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.

Skills

CSV validation

GMP compliance

CQV experience

Validation lifecycle

Documentation

Cross-functional collaboration

Data integrity

Equipment validation

Root cause investigation

On-site validation

Job description

Katalyst CRO seeks experienced CSV Engineers for on-site validation support in a regulated biopharmaceutical environment. The role centers on Computer System Validation while also supporting equipment qualification and broader CQV activities as priorities require.

Consultants will validate documentation and execute protocols, assess systems against GMP requirements, document results, investigate discrepancies, and work across Engineering, Quality, Manufacturing, Automation, IT, and system owners.