Ml Engineer Jobs

About The Position

Requirements

• At least 7 years of hands-on computerized system validation experience in FDA-regulated pharmaceutical or biotechnology environments.
• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related discipline.
• Demonstrated experience managing end-to-end GxP computerized system validation, from initial requirements through testing, approval, and ongoing lifecycle maintenance.
• Strong practical knowledge of 21 CFR Part 11, EU Annex 11, ISPE GAMP 5, and FDA Computer Software Assurance (CSA).
• Experience developing, reviewing, and approving validation documentation, including URS, IQ/OQ/PQ, RTM, risk assessments, and validation summary reports.
• Hands-on experience supporting enterprise GxP platforms; examples include Veeva Vault Quality, Veeva RIM, Veeva Medical, ServiceNow, and Qlik.
• Understanding of computerized system controls involving electronic records, electronic signatures, audit trails, user access, and data integrity.
• Familiarity with validation requirements for clinical systems such as EDC, IRT, eTMF, and CTMS, or laboratory systems such as LIMS, CDS, and ELN.
• Experience supporting computerized system qualification across SaaS, cloud-based, and traditional enterprise environments.
• Experience providing quality oversight or validation support for AI/ML-enabled computerized systems, including model criticality, intended use, and validation risk assessments.
• Knowledge of AI model lifecycle controls, independent test datasets, acceptance criteria, model monitoring, and human-in-the-loop oversight.
• Familiarity with emerging regulatory expectations for AI applications in GxP environments, including EMA Draft Annex 22.
• Experience supporting change control, deviation investigations, CAPA, supplier quality assessments, and regulatory inspection readiness.
• Strong technical documentation, analytical problem-solving, and cross-functional communication skills.
• Ability to work independently and partner effectively with IT, Quality Assurance, business process owners, and technology vendors.

Nice To Haves

• An advanced degree is preferred.

Responsibilities

• Lead and execute computerized system validation activities across enterprise GxP applications, clinical technology platforms, laboratory systems, and digital quality solutions.
• Develop and maintain validation plans, user requirements specifications, functional specifications, IQ/OQ/PQ protocols, requirements traceability matrices, and validation summary reports.
• Apply risk-based validation strategies aligned with FDA CSA, ISPE GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Provide quality oversight for enterprise platforms such as Veeva Vault, ServiceNow, and other regulated business applications.
• Evaluate system changes, software upgrades, and configuration modifications to determine validation and revalidation activities.
• Support qualification of SaaS, cloud-hosted, and on-premises GxP applications, including electronic record controls, audit trails, and access management.
• Establish and evaluate validation approaches for AI/ML-enabled GxP systems, including intended-use assessments, model risk classification, acceptance criteria, and lifecycle controls.
• Assess AI model testing practices, including test data independence, input data characterization, and safeguards against inappropriate exposure of validation datasets.
• Support monitoring strategies for AI-enabled applications, including model drift detection, performance monitoring, and evaluation of changes affecting validated system performance.
• Develop quality oversight practices for human-in-the-loop processes involving AI-assisted regulated decisions.
• Review supplier qualification documentation, technical agreements, validation evidence, and third-party quality controls for computerized systems and AI-enabled solutions.
• Support deviation investigations, CAPA activities, change control, and periodic system reviews throughout the computerized system lifecycle.
• Partner with internal stakeholders to ensure validation documentation follows ALCOA+ data integrity principles.
• Maintain inspection-ready documentation and provide computerized system validation expertise during regulatory inspections and quality audits.