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Role Description

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.

Work Location

Travel to client sites may be required based on project demands and client expectations.

Key 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.

Qualifications

• 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.

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.
• Work Environment: The work environment characteristics include a typical office environment with moderate noise levels, bright lighting, and an indoor temperate setting.

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

Legal Statement

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.