Validation Engineer III in Foster City, CA

Job Responsibilities:

• Responsible for authoring and/or revising the following documents related to GxP Systems (specifically GE iFix & Rockwell FactoryTalk View based Environmental Monitoring Systems): User Requirements Specification, Functional Requirements Specification, Design Specification, Configuration Specification, Trace Matrix, Requirements Risk Assessment, Installation, Operational and Performance Qualification protocols. Responsible for execution of authored protocols.
• Author change management records, create or revise impacted documentation and execute change implementation tasks.
• Develop decommissioning and data migration strategies for legacy systems and author validation deliverables for decommissioning systems.
• Collaborate with cross-functional teams in authoring CAPAs and Deviations.
• Perform periodic system maintenance activities such as, account management, system maintenance, system audit trail review and backup and restore testing, etc.
• Maintain system specific operational documentation such as SOPs, work instructions, business-enabling documents, training plan as well as contribute to authoring and maintenance of business SOPs.
• Coordinate with IT stakeholders for maintenance of system infrastructure, security, and vulnerability management.
• Coordinate with business stakeholders to constantly align with their needs and deliver technical and compliant solutions, as required.
• Coordinate with software vendors for change deployment, scheduling of system maintenance activities and issue management.

Requirements:

Education:

• Bachelor’s degree.

Experience:

• Minimum 5 years of experience working in an FDA regulated environment, validating computerized systems. System Administration experience is preferred but not required.
• Must be experienced in computer system validation using GAMP 5 methodology.
• Must have a good understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to environmental monitoring systems.
• Experienced in developing validation methodology for global implementation of systems.
• Experience with validation methodologies and SDLC best practices.
• Proficient in current Good Manufacturing Practices (cGMPs) requirements.
• Required Years of Experience: 5

Top 3 Required Skill Sets:

• Computer system validation using GAMP 5 methodology
• 21 CFR part 11 and Annex 11
• Change Control and Impact Assessments

Top 3 Nice to Have Skill Sets:

• Process Control Systems / Environmental Monitoring Systems technical proficiency
• Data Migration experience
• Project Management

Unique Selling Point of this role:

• Computer system validation expertise with experience in validating a variety of computer systems.

Required Degree or Certification

• Bachelor’s degree in computer science or Pharma/Biotech related field

Any Disqualifiers?

• Inadequate validation experience or testing skills
• Lack of industry standards knowledge (GAMP5, 21 CFR Part 11, GMP etc)

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