CREO

AI Engineer

• Build and Deploy AI Solutions: Design, build, test, and deploy AI-powered solutions aligned to client business requirements.
• Support AI Enablement Engagements: Contribute across the full lifecycle of client AI programs, from discovery through deployment and adoption.
• Facilitate AI Upskilling and Training: Help non-technical users understand, adopt and get value from new AI solutions.
• Drive AI Tool Fluency and Teach Back: Explore and evaluate new AI tools and frameworks to stay current.

Senior Analyst – AI Engineer

QA Engineer

• Lead and manage IT compliance and quality projects
• Deliver client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health authority regulations, privacy regulations (GDPR, CCPA, etc.) or CAP/CLIA regulations.
• Oversee the end-to-end lifecycle of IT compliance projects, from initial assessment and requirements gathering to implementation, validation, and post-implementation support.
• This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA) per FDA guidance and GAMP 5.
• Lead technical discussions, document key compliance decisions, and track action items.
• Ensure that projects meet client expectations, are completed on time, and align with relevant regulations and industry best practices (including 21 CFR Part 11, EU Annex 11), emphasizing true risk-based approaches to validation.
• Maintain personal billable utilization at the rate of 1700 hours per year.
• Develop compliance-focused client deliverables.
• Create high-quality, client-ready deliverables that communicate complex IT compliance requirements and solutions in a clear and compelling way.
• Utilize advanced skills in Excel and PowerPoint to develop detailed compliance roadmaps, IT strategy documents, system validation plans, and risk assessments.
• Design technology presentations and reports that articulate business value and demonstrate how the proposed solutions will address client compliance challenges, improve data integrity, and mitigate risks.
• Develop Policies, Procedures, Forms, and Templates to drive regulatory compliance in the IT domain.
• Develop formal systems validation documentation (eg Validation Plans, Requirements/Specifications, Risk Assessments, Test Plans, Trace Matrices etc.)
• Assist clients to improve and modernize their approaches to IT compliance
• Lead data collection, IT analysis, and assessments related to IT compliance and Data Integrity.
• Take the lead in gathering data and conducting analyses to understand and remediate client compliance challenges.
• Conduct system audits, evaluate IT systems for compliance gaps, assess data integrity risks, and identify opportunities for compliance improvement and automation.
• Assist customers to evaluate and/or implement technologies that automate compliance tasks, including ALM/VLM solutions or automated testing software, as well as ITSM solutions to manage change control.
• Design technology solutions and architectures that meet regulatory requirements and incorporate best practices for data governance and security.
• Develop sophisticated models for assessing IT compliance, cost structures, and risk mitigation.
• Experience with qualification and/or validation of on-premises and cloud-based infrastructure and applications, including SaaS.
• Manage and communicate complex IT compliance concepts to both technical and non-technical audiences; this will be critical to driving project success and ensuring that client expectations are consistently met or exceeded.
• Actively contribute to business development activities by identifying IT compliance opportunities within existing client relationships and helping to acquire new clients.
• Conduct compliance assessments, prepare proposals for IT compliance solutions, and contribute to the firm’s position as a leader in IT compliance within the life sciences industry.
• Foster relationships with senior IT and Quality executives and influence decision-makers; this will be crucial to driving revenue growth and expanding the firm’s IT compliance consulting offerings.

Senior Analyst – AI Engineer

Senior Analyst – GxP IT QA/CSV