Benjamin Herrera

Validation Specialist I 06/2023 to 06/2024

• Developed and executed comprehensive verification tests for production coordination software, SCADA systems, complex aseptic filling lines, packaging lines, lyophilizers, and other critical pharmaceutical equipment, troubleshooting where equipment behaved unexpectedly.
• Drafted and managed risk assessment documents for manufacturing lines and automation systems, collaborating with subject matter experts and Quality Operations to ensure punctual approval.
• Initiated and managed change controls for new and existing aseptic drug product manufacturing areas, systems, and equipment, overseeing the lifecycle from draft through implementation and timely closure.
• Assisted in piloting Kneat implementation at a client site to enhance documentation practices and efficiency in the Verification workflow.
• Mentored junior staff and cross-trained with other client sites to support company goals.
• Led projects in a provisional leadership role, including writing proposals for projects from $1k-$20k, while completing a formal Certified Associate in Project Management training course.
• Managed SOPs, design specifications, system overviews, and other equipment lifecycle documentation from draft through approval.

• Verified completeness and accuracy of critical process parameters and recorded data, assuring compliance with cGMPs and applicable SOPs.
• Evaluated batch records for deviations, out-of-specification results and teamed with Operations to ensure that appropriate corrective actions were taken.
• Executed user roles in relevant softwares, including SAP and Veeva eQMS, during review and approval of batch records.
• Supported QA team continuous improvement (CI) initiatives by consistently meeting standard of three business-day review for batch records, adhering to standard work practices, and completing CI projects to reduce lost time.