Computer System Validation Engineer

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.

• 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

• 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

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.