AI / ML Validation & Computer Software Assurance (Csa) Expert

Full Time Contract Role: AI/ML Validation & Computer Software Assurance (CSA) ExpertCompensation: Up to $85/hour commensurate with experienceLocation: (US Remote)Length of Contract: Up to 6 months+Position Description: We are seeking a seasoned validation expert with expertise in AI/ML Validation & Computer Software Assurance (CSA) expertise to serve as our client's embedded quality authority across digital innovation and AI project teams. This person will represent the day-to-day interests of the global validation group inside a fast-moving, technically sophisticated environment, reviewing AI/ML initiatives as they are being built, identifying necessary controls, identifying GAPs and driving GAPs to resolution in context with corporate AI/ML frameworks and standards.Responsibilities:

• Partner with Data Science, IT/Engineering, Quality, and Regulatory Affairs to embed validation and quality-by-design principles into AI development from inception (shift-left).
• Represent global validation among business and technical teams, attend sprint reviews, architecture discussions, and stage-gate decisions, not just formal quality checkpoints.
• Apply CSA's risk-based, critical-thinking approach to determine the right level of control for each AI/ML use case — ensuring teams move quickly on genuinely low-risk work while firmly enforcing rigor where patient safety, product quality, data integrity and/or corporate security is at stake.
• Coach project teams and their leadership on how to build validation and CSA thinking into their process from the start, so control isn't something bolted on afterwards.
• Translate control requirements into terms digital innovation teams will act upon, not just cite the regulation, but explain the risk in language that lands with engineers and product owners.
• Maintain a working inventory of AI/ML initiatives and current validation/control status, providing visibility to leadership.

Qualifications:

• 10+ years of experience in computer system validation/CSV within a regulated life sciences environment, including demonstrated leadership applying Computer Software Assurance (CSA) principles — critical-thinking-based risk assessment, right-sized documentation, and defensible acceptance of risk
• Thought leadership and demonstrative expertise and in validating AI/ML systems together with strong working knowledge of AI/ML models, frameworks, and solutions, sufficient to engage credibly and in detail with data science and engineering teams, including:
  • Model types (classical ML, deep learning, generative AI/LLMs, computer vision, NLP)
  • Frameworks and tooling (e.g., TensorFlow, PyTorch, scikit-learn, MLOps/LLMOps platforms, cloud AI services)
  • Training, fine-tuning, retrieval-augmented generation, prompt engineering, and model evaluation
  • AI-specific risk considerations: bias, explainability, drift, hallucination, data lineage, adversarial robustness
• Deep familiarity with 21 CFR Part 11, Part 820/QMSR, GAMP 5 (2nd Edition), EU Annex 11, ICH Q9(R1), FDA guidance on AI/ML-based SaMD and CSA, and emerging AI regulatory frameworks (e.g., EU AI Act).
• Exceptional communication and stakeholder-management skills; comfortable being the person in the room whose job is occasionally to slow things down.

Education & Certifications:

• Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Information Technology) preferred.

Equal Opportunity Employer: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.About RCM: RCM is publicly traded on Nasdaq under the symbol RCMT.  RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.