Senior Pharma Data & AI Engineer

Introduction

We are looking for a senior Data & AI Engineer / Technical Lead with hands-on experience delivering technology solutions within pharmaceutical or life-sciences environments. The ideal candidate combines strong data/software engineering capabilities with practical knowledge of regulated pharma environments, including 21 CFR Part 11, GxP/GMP, data integrity, audit trails, validation/CSA/CSV, change control, and quality processes. This is not a purely regulatory or documentation position. The candidate must be technically strong and capable of participating in customer discovery sessions, understanding pharmaceutical manufacturing/business processes, translating those requirements into technical solutions, and working hands-on with engineering teams through design, development, integration, validation, deployment, and production support.

Responsibilities

• Participate directly in technical discovery sessions with pharmaceutical customers, SMEs, architects, and engineering teams.
• Understand pharma manufacturing and quality workflows and translate business/process requirements into technical designs.
• Design and develop scalable data pipelines, integrations, APIs, applications, and AI/ML components.
• Work with structured and unstructured data originating from manufacturing, quality, laboratory, equipment, and enterprise systems.
• Design solutions with appropriate consideration for 21 CFR Part 11 requirements, including electronic records, access controls, auditability, traceability, and electronic signatures where applicable.
• Work within GxP/GMP-controlled environments and understand how regulated-system requirements affect software development and deployment.
• Support data integrity / ALCOA+ principles across data ingestion, transformation, storage, and consumption.
• Design or support audit trails and traceability for regulated data and application workflows.
• Work with validation/quality teams on Computer System Validation (CSV) / Computer Software Assurance (CSA) activities.
• Understand pharma Deviation, CAPA and Change Control processes and their impact on technology systems.
• Integrate with or work around pharmaceutical systems such as MES, LIMS, QMS, ERP and manufacturing/plant systems.
• Develop or integrate AI/ML capabilities while maintaining appropriate controls for regulated environments.
• Collaborate with onshore architects, pharma SMEs, product teams, and offshore engineering teams.
• Provide technical leadership, code/design reviews, troubleshooting, documentation, and knowledge transfer.
• Support solutions from discovery → prototype → MVP → production → enterprise deployment.

Requirements

Must-Have Skills

• 8+ years overall experience
• 3+ years in pharmaceutical/life-sciences technology environments
• 21 CFR Part 11
• GxP / GMP
• Data Integrity / ALCOA+
• Audit Trails & Traceability
• CSV / CSA / computerized-system validation
• Deviation & CAPA
• Change Control
• Regulated electronic records
• Pharmaceutical manufacturing and/or quality processes
• Python
• SQL
• ETL/ELT
• APIs
• Data integration
• Data modeling
• Data quality
• Batch and/or streaming pipelines
• Cloud/Data Platforms (AWS, Azure, or Google Cloud Platform)
• Snowflake and/or Databricks
• Relational and NoSQL databases
• Cloud storage/data-lake technologies
• Python-based AI/ML development
• AI/ML model integration