Syner-G BioPharma Group

To enable our clients to achieve success and enhance human health while inspiring our colleagues to excel! #weinspire

Staff Business Analyst

Business AnalystBusiness AnalystFull TimeRemoteTeam 201-500H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

Not specified

Bachelor Degree7 yrs expEnglish

Job Description

• 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

Job Requirements

  • Bachelor’s degree in Computer Science, Life Sciences, Engineering, Industrial Engineering, Pharmaceutical Technology, or related field
  • 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.

Benefits

  • Competitive base salary
  • Annual incentive plan
  • Comprehensive benefits
  • Flexible paid time off
  • Company-paid holidays
  • Flexible working hours
  • Remote work options for most roles

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