CSV Engineer - Regulated Systems Validation (Hybrid)

R&D Partners; Redwood City (CA); Hybrid; USD 135,000 - 166,000; Full time

Benefits offered by this job

Medical insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Online timecard approval

Job summary

R&D Partners is hiring a Computer System Validation Engineer for a 12-month, on-site contract in Redwood City with a hybrid schedule. You will lead validation strategies, create comprehensive documentation, and perform risk assessments to ensure GMP/GxP compliance across ERP, LIMS, and MES systems.

Ideal candidates have 2–5 years in CSV, strong regulatory knowledge (FDA/EMA), and excellent writing skills. Collaboration with IT, QA, and Operations is essential for successful validations and

Qualifications

• Bachelor's degree in Computer Science, Engineering, or a related field.
• 2–5 years of experience in computer system validation or related field.
• Strong knowledge of regulatory requirements (FDA, EMA) and standards (GAMP 5).
• Experience validating ERP, LIMS, MES systems.

Responsibilities

• Develop validation strategies for computer systems and software.
• Create and maintain Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
• Perform risk assessments to ensure compliance with regulatory requirements.
• Collaborate with IT, QA, and Operations to validate systems.
• Conduct validation testing and review results to meet requirements.
• Provide training on validation processes to staff.
• Participate in audits/inspections by regulatory agencies.

Skills

CSV engineering

Validation testing

Documentation

Regulatory knowledge

Independent worker

Education

Bachelor's degree in Computer Science or Engineering

Tools

IQ/OQ/PQ protocols

Job description

R&D Partners is hiring a Computer System Validation Engineer for a 12-month, on-site contract in Redwood City with a hybrid schedule. You will lead validation strategies, create comprehensive documentation, and perform risk assessments to ensure GMP/GxP compliance across ERP, LIMS, and MES systems.

Ideal candidates have 2–5 years in CSV, strong regulatory knowledge (FDA/EMA), and excellent writing skills. Collaboration with IT, QA, and Operations is essential for successful validations and