Staff Business Analyst

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., * 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.

• Bachelor's degree in Computer Science, Life Sciences, Engineering, Industrial Engineering, Pharmaceutical Technology, or related field. Equivalent experience considered., * 7â??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.

Knowledge, Skills, and Abilities:

• 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.

ESSENTIAL FUNCTIONS:

Physical Demands: The physical demands described here represent the requirements for successful performance of the essential functions. Reasonable accommodations may be made for individuals with disabilities. While performing job duties, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The role requires frequent walking and sitting, and occasional lifting of objects up to 25 pounds. Vision requirements include close vision and the ability to adjust focus.

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. Office locations are available in Greater Boston; San Diego, CA; Boulder, CO; and India.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.