CSV Engineer

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

Our client is currently looking for a CSV Engineer with Blue Mountain experience, long term contract.

The successful candidate must have the following experience:

• Responsible for developing and executing Computer System Validation (CSV) strategies to ensure GxP-compliant computerized systems meet regulatory and business requirements.
• Prepare and maintain validation documentation, including Validation Plans, Risk Assessments, Functional Requirements, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Execute validation activities for manufacturing and quality systems such as BMS, EMS, PCS, ERP, LIMS, and MES in accordance with FDA, EMA, and GAMP 5 guidelines.
• Support Software Development Lifecycle (SDLC) processes and ensure compliance with data integrity and electronic records/electronic signatures (ERES) requirements.
• Collaborate with cross-functional teams, including IT, Quality Assurance, Automation, and Operations, to deliver successful validation projects.
• Perform validation testing, review results, resolve deviations, and ensure systems operate as intended throughout the validation lifecycle.
• Assist automation teams with system configuration, I/O verification, and qualification of GMP manufacturing equipment.
• Provide technical guidance and training on CSV processes while supporting regulatory audits and inspections.
• Maintain awareness of evolving regulatory expectations and industry best practices to ensure continuous compliance and process improvement.
• Bachelor's degree in Computer Science, Engineering, or a related field with 2–5 years of CSV experience, strong technical writing skills, knowledge of FDA/EMA regulations, GAMP 5, cloud-based systems, and validation tools such as Blue Mountain RAM preferred.