Néstor R. Santana
Durham
Summary
Insightful, results-driven professional with notable success leading a broad range of Automation / IT / CSV / Analytical Equipment initiatives while participating in planning, analysis and implementation of solutions, and tools to support the business objectives. Provided expertise, guidance to direct reports and hands-on experience leading all stages of system development efforts, including functional requirements definition, design, architecture, testing and support. Outstanding implementation leader; able to coordinate and direct all phases of project-based efforts while managing, motivating and guiding teams.
Overview
32
32
years of professional experience
Work History
Senior Manager Operations Support
Fujifilm Diosynth Biotechnologies
Morrisville
01.2024 - Current
- Managing and lead the daily operations for Analytical / CSV / Project Automation teams.
- The Analytical services team is responsible for the preventive maintenance, repairs and troubleshooting, and systems integration of the site’s analytical equipment.
- The team also supports capital projects for procurement, installation, and qualification of analytical equipment.
- The Computer System Validation team is responsible for the qualification and validation of equipment control systems.
- The Project Automation team is responsible of the integration of new and existing equipment control systems into the automation system to include DCS and data historians in accordance with FDBU standards and cGMP regulatory requirements.
Principal Automation Engineer
Fujifilm Diosynth Biotechnologies
Morrisville
01.2023 - 01.2024
- Lead and manage a team of Automation Engineers responsible for the Site Automation Engineering CAPEX projects for the upstream and downstream processes.
- Support the site initiatives/capital projects from conception, design and initial specifications through completion and turnover.
- Responsible for the implementation of new and innovative technologies.
Staff Automation Engineer
Fujifilm Diosynth Biotechnologies
Morrisville
01.2021 - 01.2023
- Lead and manage a team of Automation Engineers responsible for the Site Automation Engineering CAPEX projects for the upstream and downstream processes.
- Successfully maintained ownership and accountability for SDLC deliverables of all automation capital projects to support manufacturing / PD microbials and cell culture programs.
- Successful integration of Recovery Units, CIP Skids, Small Centrifuge (CSC6), GEA Homogenizer, Steris Autoclave and Glasswashers controls upgrades.
- Ability to take additional voluntary tasks like supporting and collaborating on the company Single Use Manufacturing Strategy (SUMS) FDB initiative.
- Excellent performance and contribution to the team by providing guidance and collaboration with my peers and colleagues in all automation control systems lifecycle aspects.
- Development of Site DeltaV Configuration Standards
- Successful Standardization for the integration of Equipment PLC controlled with Supervisory Control Systems
- Develop Basic DeltaV Operation Training for Manufacturing
Sr. Automation Engineer
Novo Nordisk
Clayton
01.2016 - 01.2021
- Automation Lead for Fermentation Building in DAPI US Project.
- As leader of Fermentation Building participate on the Basic and Detail Design of the Fermentation Area Process Modules.
- Review and approve Fermentation User Requirement Specifications, Technical Specification and Functional Specifications.
- Participate in the generation and approval of Fermentation Validation Plans and Design Qualification activities.
- Responsible for Fermentation Proof of Concepts activities and all Fermentation Process Modules PCS Automation Factory and site Software Acceptance Tests.
- Design activities successfully executed and delivered on time.
- Successfully manage small teams in the delivery of Fermentation Process Modules, sSAT successful execution meeting project schedules and budget.
- Instrumental in developing and implementing Automation PCS, MES and Historian platforms in DAPI US Project.
Sr. Automation Engineer
Lilly del Caribe, Inc.
Carolina
01.2003 - 01.2016
- Promoted to lead Automation Technical Staff Meetings.
- As Data Historian and Production Reports Subject Mater Expert (SME) ensure proper system administration and provide guidance in the implementation of Routine Process Monitoring activities and support Manufacturing and Business activities.
- Provide guidance and support to Clean In Place Process Team activities.
- Become the Lilly Technical SME on eLogs / eTickets, the liaison with Global Corporate Resources to provide oversight and mentor the DeltaV integration with CSMES.
- Successfully lead the implementation of DeltaV Upgrade in Utilities, Fermentation and Purification buildings.
- DeltaV Power Users Program was successfully completed to provide support to manufacturing areas.
- Develop Productivity tools to closely monitor the manufacturing process.
- Modify and update numerous procedures in support of manufacturing and systems operations to ensure regulatory compliance.
- Instrumental in developing and implementing CSMES procedures (Change Management, DRP, BCP, etc) and guidelines for the site.
Automation Engineer
Lilly del Caribe, Inc.
Carolina
01.2002 - 01.2003
- Work proactively in the development of functional requirements and design specifications documents, code and testing activities for the new manufacturing facility in Puerto Rico and provide support to start-up activities in Biotechnology Purification areas.
- Responsible for the site Production Reports development and support the control systems interface with the Business (SAP), Continuous Historian (OSI PI) and data analysis tools (Discoverant).
- Software code configuration, verification and customer reviews were successfully completed on time.
- Develop, review and approve Purification Process Cells Functional Requirements and Design Specifications documents following the Software Development Life Cycle.
- Production Reports were successfully developed to support the site manufacturing.
Process Support Section Manager
Abbott Chemical Plant, Inc.
Barceloneta
01.2001 - 01.2002
- Promoted to lead a group of technicians and engineers to ensure current process yields, quality and throughput were achieved.
- Provide guidance in the analysis of data to identify process deviations and recommend corrective and preventive actions.
- Outstanding support to manufacturing operations avoiding process deviations, implementing changes to increase product yield and reduce cost.
Sr. Process Support Engineer
Abbott Chemical Plant, Inc.
Barceloneta
01.1998 - 01.2001
- Promoted to provide technical support and leadership to manufacturing areas, including training and new project implementations.
- Responsible for the validation of new process and to maintain current process in their validated state.
- Outstanding support to manufacturing operations avoiding and minimizing process deviations.
- Successfully implement new process that increase product yield, reduce operation cost and increase product throughput.
DCS Process System Engineer
Abbott Chemical Plant, Inc.
Barceloneta
01.1995 - 01.1998
- Worked directly in Computer Validation, executing Structural and Functional Tests in the plant Capacity Increase Project.
- Developed and executed Software and Hardware IQs.
- Excellent configuration that yielded in minimal retest and validation efforts.
- Excellent troubleshooting and implementation of configuration changes minimizing impact to manufacturing operations.
Manufacturing Technologist
Warner - Lambert, Inc.
Vega Baja
01.1994 - 01.1995
- Provided support to the implementation of new processes modifications.
- Generate and execute validation documentation, IQ/OQs.
- Successfully implemented all assigned validation activities as per project schedule.
Education
Bachelor of Science - Chemical Engineering
University of Puerto Rico
01.1994
Skills
- DeltaV
- RS3
- S88 Batch Process
- Emerson MES (Syncade)
- OSI Soft System Administration
- Client Tools
- Word
- Excel
- PowerPoint
- Communications
- Problem-solving
- Relationship-management
- SymphonX
Affiliations
- Colegio de Ingenieros y Agrimensores de Puerto Rico
- American Institute of Chemical Engineers
- Phi Sigma Alpha Fraternity
Timeline
Senior Manager Operations Support
Fujifilm Diosynth Biotechnologies
01.2024 - Current
Principal Automation Engineer
Fujifilm Diosynth Biotechnologies
01.2023 - 01.2024
Staff Automation Engineer
Fujifilm Diosynth Biotechnologies
01.2021 - 01.2023
Sr. Automation Engineer
Novo Nordisk
01.2016 - 01.2021
Sr. Automation Engineer
Lilly del Caribe, Inc.
01.2003 - 01.2016
Automation Engineer
Lilly del Caribe, Inc.
01.2002 - 01.2003
Process Support Section Manager
Abbott Chemical Plant, Inc.
01.2001 - 01.2002
Sr. Process Support Engineer
Abbott Chemical Plant, Inc.
01.1998 - 01.2001
DCS Process System Engineer
Abbott Chemical Plant, Inc.
01.1995 - 01.1998
Manufacturing Technologist
Warner - Lambert, Inc.
01.1994 - 01.1995
Bachelor of Science - Chemical Engineering
University of Puerto Rico