Job Title: Validation Engineer

Location: Foster City CA

Duration: 12 Months

Description:

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)