Position Title: Senior Digital Systems Engineer
Department: Manufacturing Operations / Quality Systems / Information Technology/Artificial Intelligence
Reports To: Executive Director; functional oversight from the Quality Director (data integrity / validation) and Medical Director
Setting: Autologous cellular-therapy manufacturing (HCT/P) under cGMP and 21 CFR Part 210, 211, 1271 (cGTP); AABB/FACT cellular-therapy standards
Position Summary
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.
Essential Duties and ResponsibilitiesArtificial 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 privileged actions independently logged and reviewed.
- Validation: apply Computer Software Assurance (CSA) and risk-based validation, change control, periodic review, and qualification testing; reference FDA 2018 Data Integrity, MHRA GxP Data Integrity, and PIC/S PI 041 guidance.
Data Retention & Records Archival
- Retention program: own the electronic-records retention and archival program; set retention to the longest applicable predicate rule (e.g., 21 CFR 1271.270, at least 10 years; AABB/FACT; Part 211.180; Part 312.62) and applicable state law.
- Long-term readability: ensure electronic records remain retrievable and human-readable across system generations, archival strategy, validated data/format migration, and preservation of audit trails and metadata at system decommissioning.
- Lifecycle: distinguish backup (recovery) from archive (retention); maintain legal-hold capability and validated secure disposal at the end of retention.
Enterprise Infrastructure & Cybersecurity
- Architect and administer servers, storage, virtualization, and cloud / SaaS platforms supporting GxP and business systems.
- Manage qualified backup and disaster recovery with periodic restore testing, endpoint protection, and network performance for manufacturing and business continuity.
- Security frameworks: implement cybersecurity controls aligned to NIST CSF, IEC 62443 (OT), and ISO 27001; protect PHI and clinical data consistent with HIPAA and a data-classification policy.
- Vendor qualification: qualify cloud / SaaS and AI vendors - supplier qualification, GAMP software categorization, data-residency and shared-responsibility assessment, and provider audits.
- Manage identity and access management, user accounts and permissions, and automation scripting for GxP-relevant workflows.
Data Analytics, Digital Transformation & Audit Readiness
- Develop dashboards, KPIs, and data pipelines connecting manufacturing and quality systems; support advanced analytics and Industry 4.0 initiatives.
- Support FDA inspections, AABB/FACT accreditation assessments, and customer audits; maintain compliance documentation and support responses to observations.
Required Qualifications
Education
Bachelor's degree in Information Technology, Computer Science, Software Engineering, Automation Engineering, Data Science, Industrial Engineering, or a related technical field. An equivalent combination of education and experience may be considered.
Experience
- 8+ years supporting validated computerized systems in a GMP/GxP-regulated manufacturing environment (biologics, cell/gene therapy, or similar).
- Experience in a cellular-therapy or HCT/P operation under 21 CFR Part 1271 (cGTP), or comparable regulated biologics manufacturing.
- 5+ years with MES and manufacturing automation / OT (PLC, SCADA, historian).
- Demonstrated experience building and implementing AI, machine learning, or advanced analytics in a regulated environment.
- Experience with computerized system validation and data-integrity programs.
- Familiarity with AABB and/or FACT standards and ISBT 128 (strongly preferred).
Technical & Compliance Skills
- Manufacturing & OT: MES administration, PLC, SCADA, historians, OPC communications, industrial networking, process control, ISA-95 / ISA-88.
- Artificial Intelligence: generative AI, LLMs, Azure OpenAI / OpenAI, RAG, vector databases, machine learning, Python, AI governance, CSA-based AI validation, prompt engineering.
- Infrastructure & Security (supporting GxP): Windows Server, virtualization, Microsoft 365 / Entra ID administration, cloud (Azure / AWS), backup & DR, networking, cybersecurity (NIST CSF, IEC 62443, ISO 27001), PowerShell / Python.
- Regulatory & Data Integrity: 21 CFR Part 11; 21 CFR Part 1271 / cGTP; cGMP / GxP; AABB and FACT standards; ISBT 128; chain of identity / custody; ALCOA+ / data integrity; CSV and Computer Software Assurance (CSA); GAMP 5; records retention & archival; HIPAA; risk management; change control.
Preferred Qualifications
- Cell therapy, gene therapy, blood banking, or HCT/P manufacturing experience.
- Experience supporting AABB and/or FACT accreditation.
- MES experience (Ignition, PAS-X, Syncade, Tulip, PharmaSuite, or similar), ideally configured for cellular therapy.
- ISBT 128 implementation experience.
- Knowledge of ISA-95 and ISA-88 standards.
- Certifications in cybersecurity, AI/ML, Microsoft/Azure/AWS, or automation.
Key Competencies
- Strong data-integrity and compliance mindset, with a product-safety orientation appropriate to patient-specific autologous products.
- Strong analytical, problem-solving, and troubleshooting abilities.
- Excellent documentation discipline.
- Ability to communicate effectively with technical and non-technical stakeholders.
- Project management and the ability to lead cross-functional initiatives independently.
- Continuous-improvement orientation.
Success Metrics
- Manufacturing and OT system uptime and reliability.
- Data-integrity and audit-trail completeness; zero critical data-integrity findings.
- Product-traceability integrity (chain of identity / custody; ISBT 128 accuracy).
- Records retention and archival compliance.
- Successful, validated MES / AI integration projects.
- FDA and AABB/FACT inspection and accreditation readiness.
- Reduction in manual processes and hybrid/spreadsheet records through validated automation.
- Compliance with 21 CFR Part 11, Part 1271 (cGTP), and cGMP requirements.
Pay: $115,000.00 - $140,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Professional development assistance
- Vision insurance
Work Location: In person
