CSV Consultant – GxP Systems Validation

Stark Pharma; Redwood City (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma is looking for an experienced CSV Consultant in Redwood City, CA to support validation activities across GxP-regulated systems in a pharmaceutical environment. The ideal candidate will have over 5 years of experience in Computer Systems Validation, with hands-on experience in validating GxP systems and knowledge of FDA regulations. Responsibilities include leading validation activities, developing documentation, and ensuring compliance throughout the system lifecycle.

Qualifications

• 5+ years of experience in Computer Systems Validation (CSV) within pharmaceutical or biotech environments.
• Hands-on experience validating GxP systems and supporting regulated system implementations.
• Strong knowledge of FDA 21 CFR Part 11, GAMP5, and GxP requirements.

Responsibilities

• Lead validation activities for GxP-regulated systems.
• Support system revalidation and data migration projects.
• Develop and execute validation documentation.
• Manage change control documentation and support deviation resolution activities.
• Collaborate with stakeholders for system implementations.

Skills

Validated systems experience

Change control processes

Regulatory compliance knowledge

Analytical skills

Documentation skills

Communication skills

Education

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

Tools

SAS Studio

Veeva Quality Docs

CTMS

TraceLink

Argus

Job description

Stark Pharma is looking for an experienced CSV Consultant in Redwood City, CA to support validation activities across GxP-regulated systems in a pharmaceutical environment. The ideal candidate will have over 5 years of experience in Computer Systems Validation, with hands-on experience in validating GxP systems and knowledge of FDA regulations. Responsibilities include leading validation activities, developing documentation, and ensuring compliance throughout the system lifecycle.