Staff Business Analyst

Syner-G • Novato, CA

1d • Hybrid

About The Position

The Validation Project Manager / Business Analyst is responsible for leading validation system implementation activities for digital validation platforms such as ValGenesis or within a regulated pharmaceutical environment. This role serves as both a project manager and a validation business analyst, bridging business, quality, and technical stakeholders to ensure successful deployment, configuration, and adoption of electronic validation lifecycle management systems. The ideal candidate has hands-on experience implementing ValGenesis for Life Sciences organizations, strong understanding of validation and compliance workflows, and the ability to drive structured requirements, system configuration, testing, and end-user readiness.

Requirements

• Bachelor’s degree in Computer Science, Life Sciences, Engineering, Industrial Engineering, Pharmaceutical Technology, or related field. Equivalent experience considered.
• 7–12 years of experience as a Business Analyst, Project Manager, or Validation SME supporting system implementation within the pharmaceutical or Life Sciences industry.
• Direct experience implementing Kneat or ValGenesis in a GxP environment is required.
• Experience working with validation, quality, compliance, or regulated manufacturing processes.
• Experience supporting cross-functional technical and validation workstreams on medium- to large-scale programs.
• Experience with CSV, GAMP 5, validation documentation, and electronic validation systems.
• Strong understanding of validation workflows including IQ, OQ, PQ, user requirements, traceability, deviation handling, and approvals.
• Ability to translate complex validation and compliance processes into system requirements and actionable configurations.
• Strong analytical and problem-solving skills with the ability to evaluate validation processes and recommend optimized future-state solutions.
• Strong project management skills including risk tracking, issue management, and timeline coordination.
• Excellent communication, facilitation, and stakeholder management skills; ability to work with Quality, IT, and Business leaders effectively.
• Strong documentation, requirements-gathering, and technical writing skills.
• Proficiency with MS Office and standard business analysis tools.
• Ability to work both independently and collaboratively across diverse teams.

Responsibilities

• Lead end-to-end project management activities related to the implementation of ValGenesis, Kneat, or similar electronic validation lifecycle management platforms.
• Conduct detailed analysis of client validation processes to document user requirements, functional specifications, system requirements, and workflow needs.
• Plan and facilitate stakeholder workshops, discovery sessions, and Conference Room Pilots (CRPs) to assess current-state validation processes and define future-state solutions.
• Configure ValGenesis or Kneat software to meet client-specific requirements including workflows, templates, user roles, and validation objects.
• Develop business requirements, configuration documents, user stories, and related documentation needed to support system implementation.
• Partner with Quality, Validation, IT, Engineering, and Manufacturing stakeholders to ensure alignment on system functionality, compliance requirements, and operational needs.
• Develop and support testing activities including unit testing, functional testing, regression testing, and user acceptance testing (UAT).
• Troubleshoot system issues, track resolutions, and coordinate with technical teams to ensure timely remediation.
• Prepare training materials and lead end-user training sessions to support system adoption and change management.
• Support go-live readiness activities including cutover planning, migration validation, and hypercare support.
• Ensure implemented solutions align with GxP expectations, validation best practices, and regulatory standards.
• Provide ongoing support, guidance, and continuous improvement recommendations for validation system usage.
• Contribute to best practices, process standards, and knowledge sharing across the project team.

Benefits

• We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture.
• This includes a competitive base salary, annual incentive plan, comprehensive benefits, and ongoing recognition and career development opportunities.
• Employees benefit from flexible paid time off, company-paid holidays, flexible working hours, and remote work options for most roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level