Oscar has more than 12 years extensive hands-on experience with validation, quality assurance, technical services, research and development within the biotechnology, solid dosage, diagnostics and medical device industries
- Successfully performed the technology and product transfer of several medical device products from Europe and USA into Puerto Rico facilities – completed the equipment and process qualifications, created and implemented the Change Control program, related SOP’s and manufacturing batch records.
- Developed and executed Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) protocols for several new systems being installed in the manufacturing area.
- Performed equipment and packaging validation activities for a new line of products. Activities included the developing and execution of IQ/OQ/PQ protocols for packaging equipment including zebra printers, scanners, sealing machines, wrapping machines. Also provided support for new package design, suppliers qualification, labels/boxes design among other product development activities.
- Developed Standard Operating Procedures (SOP’s), maintenance and calibration records related to the operation and maintenance of new systems. Trained all personnel in the implementation of the new procedures, standards and specifications.
- Generated Process Validation Protocols and provided support in the execution of EtO Sterilization Re-Validation activities for medical devices products, assessed laboratory results and prepared final validation reports.
- Responsible for performing a Decommissioning and Historical Assessment for laboratory and manufacturing (Injectables, Solids, Creams and Liquids) area equipment and utilities.
- Developed and executed qualification protocols for manufacturing/packaging equipment including Alloyd Heat Seal machines, Norwood Lid stamping machines and Multivac forming, sealing and stamping machine.
- Developed Validation Master Plans (VMP), Revalidation Plans, budget estimates and allocation, project schedules, resources allocation plans.
- Provided support in the preparation of IQ/OQ/PQ and Decommissioning Protocols for manufacturing equipment including tanks, pumps, autoclaves, freezers, refrigerators, coaters, incubators.
- Actively participated as Quality Engineering Department representative in the FDA and Europe pre-approval inspection readiness core team that achieved the FDA and Europe pre-approvals with zero (0) major observations.
- Prepared and executed IQ, OQ and PQ protocols for portable tanks, pumps, and portable CIP systems.
- Developed and executed Installation/Operational Qualification Protocols and Commissioning Documents for manufacturing equipment including portable tanks and portable pumps; HVAC, WFI distribution system and Nitrogen distribution system. Prepared technical and summary reports for final approval, developed all SOP’s related to the operation and maintenance of validated systems.
- Performed validation activities to support equipment and utilities qualifications for the start-up of a new biotech building. Prepared commissioning documentation, Validation Plans, IQ/OQ protocols for utilities and process equipment including compressed air, water systems, and autoclaves.
- Developed and executed IQ and OQ protocols for the start-up of new biotech process equipment, including Clean in Place systems, storage and solutions preparation tanks, pumps, transfer panels, freezers, incubators, ovens and autoclaves. Additional tasks included the creation of Turnover Packages (TOP’s), writing and execution of engineering studies reports and the development of final qualification reports.
- Prepared and executed IQ, OQ and PQ’s protocols of process, packaging, coating and compress equipment (Glatt, equipment and solution preparation system), mocon, pharmapaktor, pumps, v-blenders, Fette, coaters, cap machines, vision systems and tablets counters.
- Validation Engineer – BioTeknica, Inc.
- Senior Validation Consultant – R-A Consulting, Inc.
- Validation Consultant – VTS Consultants Inc.
- Senior Manufacturing/Packaging Engineer – Boston Scientific
- Senior Validation Engineer – Merck Sharp & Dohme,
- Senior Validation Engineer – Integra Neurosciences
- Senior Validation Engineer – Abbott Biotechnology Ltd.
- M.S., Engineering Management – Polytechnic University, Hato Rey, Puerto Rico
- B.S., Industrial Engineering – Polytechnic University, Hato Rey, Puerto Rico
- Project Management Certification
- Occupational Safety & Health Administration (OSHA)