Life Sciences Solutions Architect

Summary

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, Lab Ware, Val Genesis, 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

• Lead pre-sales CQV and AIQ service design for POD teams across lab and manufacturing environments
• Engage in client discovery sessions and solution presentations during pre-sales
• Develop and maintain SOPs, validation documentation, and compliance templates
• Align validation frameworks with regulatory standards (FDA, EMA, GxP) and internal QA policies
• Collaborate with digital and data architects to integrate validation into broader IT/AI transformation efforts
• Mentor project teams and support continuous improvement of delivery playbooks
• Provide strategic insight on tool selection and best practices in digital validation platforms
• Responsible for the technical design, technical content (architecture and design), integrity and quality of solution and how they impact the business outcomes
• Communicate project statuses with supervisor and customer on a weekly and monthly basis
• Develop future service offerings, GTM strategies, training content, etc.
• Travel as needed, attend trade shows to engage with potential and existing partners

• Mid-Senior level

• Full-time

• Information Technology

• IT Services and IT Consulting

Location:

Atlanta, GA

Salary: $118,200 - $204,300