Senior CSV Engineer — GMP Validation & CQV Specialist

Creative Solutions Services, LLC; Boston (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC is seeking experienced CSV Engineers to provide onsite validation support in a regulated biopharmaceutical manufacturing environment. The role focuses on computer system validation while supporting equipment qualification and broader CQV activities as priorities require.

You will support validation documentation and execution, assess computerized systems against GMP, and document test results while working cross-functionally with Quality, Engineering,

Qualifications

• Approximately 5–10 years of validation experience within GMP-regulated environments.
• Strong CSV validation experience.
• Experience validating GMP computerized systems.
• Knowledge of the CSV lifecycle: planning, requirements, risk assessment, testing, traceability, and documentation.
• Understanding of data integrity and GMP expectations for computerized systems.
• Equipment validation / CQV experience in addition to CSV.
• Ability to document results and investigate discrepancies.
• Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
• ValGensis is a plus.

Responsibilities

• Provide onsite validation support in a regulated biopharmaceutical manufacturing environment.
• Support validation documentation and execution activities.
• Assess computerized systems against GMP requirements.
• Execute approved validation protocols and document test results.
• Investigate discrepancies and report findings.
• Collaborate with Quality, Engineering, Manufacturing, IT, and system owners.

Skills

CSV validation

GMP validation

Data integrity

Risk assessment

Test documentation

Cross-functional collaboration

Tools

ValGensis

Job description

Creative Solutions Services, LLC is seeking experienced CSV Engineers to provide onsite validation support in a regulated biopharmaceutical manufacturing environment. The role focuses on computer system validation while supporting equipment qualification and broader CQV activities as priorities require.

You will support validation documentation and execution, assess computerized systems against GMP, and document test results while working cross-functionally with Quality, Engineering,