Michael Estacio Email & Phone Number

South San Francisco, California, Us

- Lead Business Process Harmonization in CSV practices for South San Francisco Manufacturing, ensuring alignment with industry best practices and regulatory standards.- Acted as the Implementation Lead and technical Subject Matter Expert (SME) for the successful implementation of Global MES PharmaSuite in the CPMF area. Ensured project success, adherence to schedule, CSV standards, and compliance. Led and participated in validation, implementation, training, and organizational change management activities.- Provided technical expertise as the SME for MES Syncade (Emerson) implementation and maintenance at the Genentech's Clinical Supply Center manufacturing facility (CSC). Supported change management, investigations, problem incidents, and engaged with end-users to ensure smooth operations.- Mentored and onboarded new team members, sharing knowledge and best practices to facilitate their professional growth and contribute to the team's overall success.- I am an Innovation Journey Idea candidate. My idea aims to empower end users by providing them with access to inventory data between ERP/MES systems through a dashboard. This solution has the potential to effectively reduce downtime caused by inventory issues. The idea has progressed through several stages, including scoping, problem exploration, solution development, and business model formulation. Currently, it is at the pitching phase, where I am presenting the idea to stakeholders and decision-makers.

South San Francisco, California, Us

- Acting as the Manufacturing Execution System (MES) system owner, responsible for maintaining the overall validated state of POMSnet and PharmaSuite. Ensured compliance with regulatory standards and oversaw system maintenance and upgrades.- Served as the Product Lifecycle Management (PLM) system owner, responsible for maintaining the overall validated state of Basecamp 1.0. Implemented change control processes and collaborated with stakeholders to ensure system integrity and data accuracy.- Led a successful Basecamp 1.0 Fit Gap Analysis for a recent PLI, identifying areas for improvement and recommending solutions to enhance system performance and functionality.- Supported site inspections and audits, actively participating in system risk assessments and providing expertise during the review and approval of system lifecycle documents.

South San Francisco, California, Us

- Acted as the Implementation Lead and technical Subject Matter Expert (SME) for the successful implementation of Global MES PharmaSuite in the CPMF area. Ensured project success, adherence to schedule, CSV standards, and compliance. Led and participated in validation, implementation, training, and organizational change management activities.- Served as the MES Integration Lead/SME for various projects, overseeing the integration of external systems (e.g., PLM/POMSnet auto recipe creation) and enhancing existing integrations (e.g., SAP Product Waste from POMSnet, Sample Delivery LIMS via POMSnet batch execution, and Production Version from SAP to PharmaSuite) to support business needs and demands.- Project Manager for the MES EBR Purification CHO Project, successfully delivering new functionality such as Dynamic Operations, custom reports, and redline processes to meet business requirements.- Designed and validated Custom Crystal Reports as the MES Custom Reports architect, leveraging an in-depth understanding of the POMSnet database structure and developing custom database objects/scripts to integrate with various Crystal Report designs.- Managed and supported system enhancements and fixes, including system build installation and configuration (POMSnet, OpsTrakker, PharmaSuite), as well as vendor upgrades/patches over the last 10+ years.- Provided MES Subject Matter Expertise (SME) for various Global Roche/Genentech Projects, including SingleLIMS, Phoenix/Veeva, Basecamp 1.0/2.0 (PLM), ASPIRE, and Global Infrastructure initiatives.- Mentored junior members of the support group and contractors, fostering their professional growth and contributing to the overall success of the team.- Provided on-call support for MES/SAP/eEUL systems, ensuring timely resolution of critical issues and minimizing downtime.

South San Francisco, California, Us

- Project Manager/Technical SME for the POMSnet EBR Implementation to convert paper ticket templates to electronic MES Recipe Templates in Cell Culture Seed Train.- Lead architect in the design, validation and enhancements of POMSnet Oracle Interface to External Systems (SAP, LIMS, EDMS). This eliminated middleware software and reduced maintenance costs.- Business analyst for EIS Incorporated MES Solution - eEUL (OpsTrakker) implementation in CPMF, which included drafting system documents, developing the implementation protocols and validation testing.- Business analyst for the creation of the MES standard test scripts library, which led to a 60% reduction in test preparation and execution times for most MES changes.

South San Francisco, California, Us

- Manufacturing Campaign support for Commercial CHO products from Seed to Production scales.- Small scale simulation studies in bioreactors to support Commercial CHO products manufacturing and characterization studies.