Computer System Validation Engineer

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 to ensure all computer systems and software meet regulatory standards. The role focuses on planning, executing, and documenting validation activities to guarantee data integrity and system reliability.

The 12-month contract is onsite in Redwood City, CA with a hybrid schedule. The ideal candidate will have 2–5 years of CSV experience, strong regulatory knowledge (FDA/EMA), and excellent documentation skills.

Qualifications

• Bachelor’s degree in Computer Science, Engineering, or a related field.
• Experience with validation across GMP/regulated environments is preferred.
• Familiarity with GAMP5 and regulatory expectations is beneficial.

Responsibilities

• Develop and implement validation strategies for computer systems and software applications.
• Create and maintain validation documentation, including IQ/OQ/PQ and Validation Reports.
• Perform risk assessments to 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 on validation processes.
• Stay updated on regulatory changes to maintain compliance.
• Participate in audits and inspections by regulatory agencies.
• Execute Validation Project Plans for manufacturing GxP systems (BMS, EMS, PCS).
• Support the execution of VPPs to qualify systems for GMP equipment per SDLC and GAMP5 standards.
• Assist site automation groups in configuring I/O and CSV protocol requirements.
• Independently perform CSV lifecycle deliverables (FRS, CS, ERES, RA, DI, IQ/OQ/PQ, Summary Report).

Skills

Regulatory knowledge

Documentation skills

Analytical thinking

Communication skills

Independent worker

Team collaboration

CSV certification

Education

Bachelor’s degree in Computer Science/Engineering

Tools

Blue Mountain RAM

Job description

We are hiring a highly skilled Computer System Validation Engineer to join our team. The CSV Engineer will be responsible for ensuring that all computer systems and software used comply with regulatory requirements and industry standards. This role involves planning, executing, and documenting validation activities to ensure the integrity and reliability of these systems.

This is a 12-month contract onsite in Redwood City, California hybrid schedule.

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 compliance with regulatory requirements.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
• Conduct validation testing and review test results to ensure systems meet specified requirements.
• Provide training and support to staff on validation processes and procedures.
• Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.
• Participate in audits and inspections by regulatory agencies.
• Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, BMS, EMS, & PCS.
• Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards
• Assist site Automation groups in configuring I/O and executing CSV protocol requirements.
• Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report

Qualifications

• Bachelor’s degree in Computer Science, Engineering, or a related field.
• Minimum of 2-5 years of experience in computer system validation or a related field.
• Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
• Experience with validation of various types of systems, including ERP, LIMS, and MES.
• 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.
• Preferred: Certification in Computer System Validation or related areas.
• Experience with cloud-based systems and software validation, experience with Blue Mountain RAM.
• $135,200-$166,400

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.