Jeff Gabaldon

Accomplished Engineering, Maintenance, and Quality professional. Experience in Manufacturing and Automation Engineering, Systems Integration, Calibration and Quality. Certified Metrologist and Certified Quality Auditor with significant experience in the biomedical and pharmaceutical industries. Background includes start-up and transition from new construction to operational mode of various pharmaceutical and biomedical manufacturing facilities. Includes Project Management, technology transfer, scale-up, and Asset Lifecycle Management. Emphasis on meeting GXP, regulatory, internal, and external customer requirements. Experience with developing, implementing, and maintaining effective processes to support the business and provide return on investment. Proficient with implementing and maintaining a robust CMMS (Blue Mountain, Maximo, SAP EAM, etc.), and an Asset Lifecycle program. Proven leadership in building and managing various departments. FDA, EMEA, and other audit agency experience. Very familiar with ISO 13485, ISO 17025, ISO 14644-1 (Fed Std 209E), and 21 CFR Parts 11, 210, 211 and 820. Ensures program state of readiness and high ethical standards while maintaining the company’s strategic and financial goals.

• At Gilead Sciences manufacturing facility in La Verne, CA, developed a new Equipment Maintenance program based on equipment categorization and criticality and performed OEE (Overall Equipment Effectiveness) on existing and new manufacturing and filling equipment. Improved equipment efficiency by 19% and was able to improve the vendor maintenance program and immediately save $200k.
• At Pacira, built a team of diverse maintenance, and automation engineers and calibration technicians to support manufacturing and business needs. Provided support for a new pharmaceutical capacity expansion manufacturing suite through the selection of utilities, instrumentation, automation programming, calibration, and commissioning.
• At Grifols, reorganized the Manufacturing Technical Support (MTS) department to better reflect the needs of the business units supported. Augmented team with Automation Engineers and Mechanical Engineer to upgrade legacy equipment, and to support new product lines. Took on new role in the Manufacturing Sciences department as Process Development Engineer to transfer multimillion-dollar manufacturing lines from Barcelona, Spain to San Diego. Developed User Requirement Specifications and Capital Expenditure Requirements for entire projects.
• At Genentech, participated in establishing the Instrumentation Services Group, consisting of the calibration program and the Primary Standards Laboratory, including obtaining ISO 17025 accreditation for the Primary Standards Laboratory and Metrology program through A2LA.