Senior Digital Systems Engineer

The Senior Digital Systems Engineer designs, implements, and optimizes the digital manufacturing, automation, and artificial-intelligence systems that support the autologous cellular-therapy operation within a GMP- and GTP-regulated environment. Operating under 21 CFR Part 210, 211, 1271 (current Good Tissue Practices) and 21 CFR Part 11, and consistent with AABB and FACT cellular-therapy standards, the role is the technical bridge between Manufacturing Operations, Quality Systems, Automation, and Information Technology for the secure, compliant operation of the systems that produce patient-specific products (e.g., BMA/BMAC, PRP, and bone-marrow-derived MSC expansion).

This is a senior, architecture- and compliance-focused position centered on manufacturing execution systems (MES), operational technology (OT), computerized system validation, data integrity, and AI platforms. A central mandate is data integrity and product traceability, enforcing chain of identity and chain of custody for autologous products, ISBT 128 labeling, electronic batch records, audit-trail integrity, and records retention across the full data lifecycle, together with the responsible integration of AI into manufacturing and quality operations under current FDA expectations.

• Artificial Intelligence – Strategy, Platform & Governance
  • Design, build, implement, and maintain enterprise AI platforms supporting drug development through clinical trials.
  • Governance: develop AI governance aligned with current FDA expectations, including the Agency's credibility / context-of-use framework (2025 draft AI guidance) and Computer Software Assurance (CSA, finalized 2025) for production and quality-system software.
  • Model lifecycle: establish controls for responsible AI use, model drift monitoring, retraining governance, model/version audit trails, and training-data provenance for models built on SOPs, batch records, and quality documentation.
  • GxP guardrails: require human-in-the-loop review for any AI output informing GxP or clinical decisions (e.g., deviation management, quality oversight); prohibit autonomous GxP or clinical release decisions.
  • Data confidentiality: maintain secure internal AI environments; prohibit transmission of PHI, proprietary, or GxP data to external or public LLMs.
  • Build and deploy AI solutions (LLMs, generative AI, RAG, knowledge management, predictive analytics, machine learning, intelligent automation, copilots) with validation proportionate to risk, including audit trails, electronic signatures, access controls, version and model change management, and CSA-based assurance.
• MES & Manufacturing Systems
  • Administer, configure, and optimize the MES and electronic batch records for autologous cellular-therapy and biologic products.
  • Support integration between MES, ERP, LIMS, SCADA, PLC, historian, environmental monitoring, and quality systems, aligned to ISA-95 and ISA-88.
  • Develop secure interfaces and APIs enabling AI systems to interact with the MES while maintaining regulatory compliance and data integrity.
• Cellular-Therapy Traceability & Product Identity
  • Chain of Identity / Chain of Custody: design and maintain systems that enforce a vein-to-vein chain of identity and chain of custody for patient-specific products, from collection through processing to administration.
  • ISBT 128 labeling: implement and validate ISBT 128 (ICCBBA) product identification and labeling across MES / LIMS / label-print systems.
  • cGTP data: support 21 CFR Part 1271 requirements – donor-eligibility determination records, product tracking and tracing, and adverse-reaction reporting.
  • Ensure computerized systems support AABB and FACT cellular-therapy standards and accreditation.
• Operational Technology (OT)
  • Support and maintain PLCs, SCADA, HMIs, industrial PCs, process control systems, manufacturing networks, historians, environmental monitoring, building management, and laboratory instrument interfaces.
  • Diagnose and resolve OT issues; perform root-cause analysis for automation and control-system failures; maintain OT documentation and change control.
  • OT cybersecurity: implement controls per IEC 62443, support network segmentation and secure architecture, and lead vulnerability assessment and remediation for industrial control systems.
• Data Integrity, Validation & Regulatory Compliance
  • Applicable requirements: ensure computerized systems comply with 21 CFR Part 11 and the applicable predicate rules, 21 CFR Part 1271 (cGTP), Part 211 (cGMP), and Part 312 (clinical), plus Annex 11, GAMP 5, ALCOA+, and the company QMS.
  • Audit-trail governance: design systems for complete audit trails and enable SOP-governed audit-trail review; such review is performed independently by Quality Assurance, not by this role, to preserve segregation of duties.
  • Data-integrity controls: control and eliminate hybrid systems and uncontrolled spreadsheets; enforce time synchronization (NTP) for reliable timestamps; apply least-privilege and privileged-access management, with this role's…