CSV / CQV Engineer

Stark Pharma Solutions Inc; Worcester (MA); On-site; USD 100,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc in Massachusetts is seeking a CSV / CQV Engineer to support validation activities in a regulated biopharmaceutical manufacturing environment. The role focuses on Computer System Validation while also supporting equipment qualification and CQV activities.

You will collaborate with Quality, Engineering, Automation, Manufacturing, and IT teams to prepare, execute, and document validation protocols, manage risk assessments, and maintain traceability across multiple

Qualifications

• 5–10 years of validation experience in a GMP-regulated environment.
• Strong experience in Computer System Validation (CSV).
• Experience with GMP computerized systems.
• Knowledge of the CSV lifecycle.
• Understanding of GMP and data integrity requirements.
• Experience with equipment validation or CQV.
• Cross-functional communication skills.
• ValGenesis experience is a plus.

Responsibilities

• Support Computer System Validation activities.
• Validate GMP computerized systems.
• Prepare and execute validation protocols.
• Support validation planning and risk assessments.
• Maintain validation documentation and traceability.
• Document testing activities and results.
• Investigate and document validation discrepancies.
• Support equipment qualification and CQV activities.
• Work with Quality, Engineering, Automation, Manufacturing, and IT teams.
• Support multiple validation projects and workstreams.

Skills

CSV (Computer System Validation)

CSV lifecycle

GMP data integrity

GMP computerized systems

Cross-functional communication

ValGenesis experience

Job description

Position: CSV / CQV Engineer
Location: Massachusetts
Duration: Long Term

Job Overview

We are seeking a CSV / CQV Engineer to support validation activities in a regulated biopharmaceutical manufacturing environment. The role will focus on Computer System Validation (CSV) while also supporting equipment qualification and CQV activities.

Key Responsibilities

• Support Computer System Validation activities.
• Validate GMP computerized systems.
• Prepare and execute validation protocols.
• Support validation planning and risk assessments.
• Maintain validation documentation and traceability.
• Document testing activities and results.
• Investigate and document validation discrepancies.
• Support equipment qualification and CQV activities.
• Work with Quality, Engineering, Automation, Manufacturing, and IT teams.
• Support multiple validation projects and workstreams.

Required Qualifications

• 5 10 years of validation experience in a GMP-regulated environment.
• Strong experience in Computer System Validation (CSV).
• Experience with GMP computerized systems.
• Knowledge of the CSV lifecycle.
• Understanding of GMP and data integrity requirements.
• Experience with equipment validation or CQV.
• Experience executing validation protocols.Experience documenting and resolving validation discrepancies.
• Strong cross-functional communication skills.
• ValGenesis experience is a plus.