Thomas Hilgert

About Thomas Hilgert

Senior Validation Professional | Driving Operational Excellence in Biotech I…

Experience

1. Expert Validation Engineer

   Novartis

   Mar 2022 — Present · San Diego, CA, US

   Spearheaded the development, review, and execution of validation protocols (IQ, OQ, PQ). Ensured compliance with GMP and regulatory requirements, enhancing operational efficiency. Conducted risk assessments and implemented corrective actions, safeguarding product quality. Maintained meticulous records for audits and inspections, ensuring seamless regulatory compliance. Collaborated with cross-functional teams to resolve validation-related issues and drive continuous improvement. Trained staff on validation procedures, fostering a culture of quality and compliance.• Worked closely with team members to develop innovative solutions and drive project success.• Certified SOP Management System Author: Developed and updated Standard Operating Procedures (SOPs) and Work Procedures, ensuring compliance and efficiency.• Engaged in annual internal audits and global headquarters audits, ensuring compliance and operational excellence.• Operated ERP, QMS, and Data Management Software systems such as BMRAM, SAP, ACE, CONDOR, D2 ESOPS, Master Control. Understand and follow ISO 9001, FDA 21 CFR Part 210, 211, and ICH Q7 guidelines.

Education

• Stockton University

  B.S.

  1989 — 1993

Skills

• Paleontology
• Validation
• Instrument Validation
• Validation Reports
• Fisheries
• In Vivo
• Laboratory Equipment
• Laboratory
• Biopharmaceuticals
• Biotechnology
• Graphic Design
• Animal Husbandry
• Assay Development
• Dna
• Zoology
• Veterinary Medicine
• Fishing
• Marine Biology
• Lifesciences
• Purification
• Laboratory Skills
• Pcr
• V&V
• Clinical Development
• Glp
• Elisa
• Research
• Microbiology
• Fda
• Life Sciences
• Vaccines
• Quality Assurance