Hybrid CSV Engineer for GMP Computer Systems

Discover International; San Francisco (CA); Hybrid; USD 199,752,000 - 315,470,000; Full time

Job summary

Discover International seeks a Validation Specialist for a 12-month hybrid contract in San Francisco. You will develop validation strategies for computer systems and software, and create Validation Plans, IQ/OQ/PQ, and Validation Reports.

Collaborate with IT, QA, and Operations to validate ERP, LIMS and MES systems, perform risk assessments, and ensure regulatory compliance with FDA/EMA and GAMP5. Strong documentation and problem-solving skills required.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or related field.
• Minimum 2–5 years in computer system validation or related field.
• Strong knowledge of FDA/EMA regulations and GAMP 5.
• Experience validating ERP, LIMS, and MES systems.
• Excellent documentation and technical writing skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.
• Certification in Computer System Validation preferred.
• Experience with cloud-based systems and software validation.

Responsibilities

• Develop and implement validation strategies for computer systems and software applications.
• Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
• Perform risk assessments to identify potential issues and ensure regulatory compliance.
• Collaborate with IT, QA, and Operations to validate systems.
• Conduct validation testing and review results to ensure requirements are met.
• Provide training and support to staff on validation processes.
• Stay current with regulatory changes to ensure ongoing compliance.
• Participate in audits and inspections by regulators.
• Execute Validation Project Plans (VPPs) for GMP systems and SDLC per GAMP5.

Skills

Regulatory compliance

Validation testing

Documentation

Risk assessment

Cross-functional collaboration

Analytical skills

Communication

Independent work

Teamwork

Training staff

Education

Bachelor’s degree in Computer Science or related field

Tools

Blue Mountain RAM

Job description

Discover International seeks a Validation Specialist for a 12-month hybrid contract in San Francisco. You will develop validation strategies for computer systems and software, and create Validation Plans, IQ/OQ/PQ, and Validation Reports.

Collaborate with IT, QA, and Operations to validate ERP, LIMS and MES systems, perform risk assessments, and ensure regulatory compliance with FDA/EMA and GAMP5. Strong documentation and problem-solving skills required.