Validation experience with sterile fill-finish, isolator or RABS automation, and EMS/PAS systems supporting EU GMP Annex 1 and a Contamination Control Strategy.
Experience with automated visual inspection (USP <790>/<1790>) and validation of AI/ML-enabled systems.
Experience with combination products or device assembly (21 CFR Part 4, 21 CFR Part 820/QMSR, FDA Computer Software Assurance guidance), or with serialization (DSCSA, EU FMD).
MES/electronic batch record experience, including ISA-88 recipe management, review by exception, and ISA-95 enterprise integration.
Knowledge of OT cybersecurity (ISA/IEC 62443), alarm management (ISA-18.2), and cloud/SaaS supplier oversight.
Familiarity with ICH Q10, EU GMP Annex 15, and the evolving EU GMP Annex 11 revision and Annex 22 (Artificial Intelligence).
Greenfield, start-up, or large capital project experience.
Experience supporting FDA, EMA, or other regulator inspections, including pre-approval or pre-license inspections.
Experience with digital validation tools (e.g., Kneat, ValGenesis) and platforms such as DeltaV, Rockwell, Siemens, PAS-X or Syncade, LabWare, Empower, OSIsoft PI, and SAP.
Strong technical writing skills.