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The Life Sciences Solution Architect will play a critical role in pre-sales engagement, solution design, development of commercial terms, contract negotiations and closing activities for programs in life sciences. This individual will serve as the subject matter expert for validation programs as well as Commissioning, Qualification, and Validation (CQV) and Analytical Instrument Qualification (AIQ) that bridge validation compliance with digital transformation efforts, enabling scalable delivery across GMP manufacturing and lab operations.
Delivers expertise to expand Insight Global | Evergreen's presence across manufacturing sites, analytical labs, and quality systems environments. The ideal candidate is an experienced leader in the industry and SME of validation who can interface with clients, design efficient and compliant solutions, and partner with Delivery Teams through execution while maintaining alignment with FDA and GxP standards.
Education:
Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, or Engineering (required)
Master’s degree (MS/MBA) or certifications in Regulatory Affairs, Pharmaceutical Engineering, or Six Sigma (preferred)
Experience:
8-12 years in CQV and/or AIQ roles in pharma, biotech, CDMO, or medical devices
Deep understanding of 21 CFR Part 11, ALCOA+, and GAMP 5
Familiarity with LIMS, Empower, LabWare, ValGenesis, or Kneat preferred
Exposure to digital validation or integration with AI/ML platforms a plus
Skills:
Strong client-facing communication and documentation skills
Leadership in POD or validation team management
Ability to develop SOPs, validation templates, and solution playbooks
Location: Atlanta, GA
Salary: $118,200 - $204,300