Darren Hankins

• Migrated and validated BAS system to Siemens Desigo.
• Authored SOPs and managed field execution documentation.

• Delivered CSV and IQ/OQ/PQ documentation for LIMS and Empower.
• Led validation training programs and regulatory alignment.

• Supported equipment validation, SAT, and audit documentation.
• Served as SME during regulatory inspections.

• Validated Empower 3 and supported TrackWise & QRMS systems.
• Managed deviation reporting and inspection readiness.

Lead Systems & CSV Engineer (Model-Based Approach)

In my role as a Lead Systems and CSV Engineer, I leverage Model-Based Systems Engineering (MBSE) to ensure a structured, visual, and traceable framework for system design, validation, and lifecycle management. MBSE allows me to integrate complex requirements, system architectures, and compliance needs into a single digital thread, improving accuracy, efficiency, and regulatory alignment.

How I Apply MBSE in My Role
System Modeling with SysML & Digital Twins

Use SysML diagrams (e.g., block definition diagrams, activity diagrams, and sequence diagrams) to model system interactions and trace requirements.

Create digital twins of critical systems to simulate validation scenarios and reduce physical testing time.

Requirements Traceability & Validation

Develop a requirements hierarchy and link URS → FRS → DS → V&V activities using traceability matrices within MBSE tools.

Automate traceability to ensure every validation test maps directly to regulatory and business requirements.

Risk-Based Validation (GAMP 5)

Integrate Failure Mode and Effects Analysis (FMEA) and risk matrices within the MBSE model to drive risk-based CSV.

Model test cases and verification plans directly from system architecture models, improving alignment with 21 CFR Part 11 and Annex 11.

Lifecycle & Change Management

Use MBSE frameworks to manage system changes, ensuring updates are analyzed for impact and revalidated through model-linked documentation.

Maintain living models of all validated systems, reducing redundant documentation and improving audit readiness.

Cross-Disciplinary Collaboration

Present system models to QA, IT, R&D, and manufacturing teams for clarity and faster approval.

Enhance communication across teams by providing visual architecture and workflow models rather than static documents.

Benefits of My MBSE Approach
Improved Compliance: Every requirement, test, and risk is linked to a single source of truth.

Reduced Validation Time: Automated generation of validation documents from system models.

Enhanced Decision-Making: Early simulation and modeling highlight design flaws before implementation.

Regulatory Audit Readiness: Digital models with embedded test evidence provide a clear audit trail.

Would You Like Me To?
I can create a one-page “MBSE at Versita” outline for your resume or portfolio, showing how you apply MBSE in CSV and regulated environments. It could include:

A SysML diagram example of a validation system flow.

A mini case study of MBSE improving a CSV project.

A 3–4 bullet resume section showcasing MBSE leadership.

Would you like me to draft that MBSE-focused resume/portfolio section with a diagram?

• Developed full validation lifecycle documents for SCADA, BAS, and data systems.
• Led FAT/SAT/IQOQ execution and server validation for GxP compliance.
• Validated SAP ECC and integrated laboratory instrumentation.

• Supported Da Vinci and Ion system validation under ISO 13485 and 21 CFR 820.
• Managed change control, SOP updates, and QMS integration.

• Oversaw Empower 3 and SCADA system integration and qualification.
• Directed equipment decommissioning and data migration.

• Validated Hamilton robotics, ACE BPM, and Empower SQT tools.
• Conducted full-spectrum testing: regression, performance, functional.

• Led validation of clinical data systems, TrackWise, and CTMS.
• Ensured GCP and 21 CFR Part 11 compliance.

• Validated LabVantage LIMS and LC-MS/MS equipment.
• Authored IQ/OQ protocols and supported GMP standards.

• Conducted SQL LIMS and LabVantage configuration testing.
• Executed functional verifications and deployment testing.

• Implemented LabWare LIMS in QC and Clinical operations.
• Conducted system migrations and compliance validation.