CSV Engineer: GxP Validation & Compliance Pro

Discover International; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Discover International is seeking a CSV Engineer with Blue Mountain experience to join our long-term contract engagement in San Francisco. The role focuses on developing and executing Computer System Validation strategies for GxP systems and ensuring regulatory alignment with FDA/EMA guidelines.

You will prepare validation documentation, support SDLC processes, and collaborate with IT, QA, Automation, and Operations to drive successful validation projects.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or related field required.
• 2–5 years of CSV experience preferred.
• Familiarity with FDA/EMA regulations and GAMP 5 desirable.
• Strong technical writing and documentation skills.

Responsibilities

• Develop and execute CSV strategies to ensure GxP compliance and meet regulatory/business requirements.
• Prepare and maintain validation plans, risk assessments, and IQ/OQ/PQ protocols and reports.
• Validate manufacturing/quality systems (BMS, EMS, PCS, ERP, LIMS, MES) per FDA/EMA/GAMP 5 guidelines.
• Support SDLC processes and ensure data integrity and ERES compliance.
• Collaborate with IT, QA, Automation, and Operations to deliver validation projects.
• Conduct validation testing, review results, resolve deviations, and ensure lifecycle readiness.
• Provide guidance and training on CSV processes and support regulatory inspections.

Skills

CSV validation

GxP compliance

Regulatory knowledge

Technical writing

Cross-functional teamwork

Education

Bachelor's degree in Computer Science, Engineering, or related field

Tools

Blue Mountain RAM

Job description

Discover International is seeking a CSV Engineer with Blue Mountain experience to join our long-term contract engagement in San Francisco. The role focuses on developing and executing Computer System Validation strategies for GxP systems and ensuring regulatory alignment with FDA/EMA guidelines.

You will prepare validation documentation, support SDLC processes, and collaborate with IT, QA, Automation, and Operations to drive successful validation projects.