Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Generic

Julian Montoya-Zapata

Arlington,MA

Summary

Highly skilled Manufacturing Execution Systems (MES) Lead with extensive experience in designing, developing, documenting, and implementing MES solutions and integrating them with Enterprise Resource Planning (ERP) systems and control equipment. Expert in configuring Electronic Batch Records (EBR) and providing organization oversight for complex systems. Able to work closely with business management and users to strategically define needs and design solutions that add value. Proven track record of directing teams in the design, development, and implementation of MES solutions.

Overview

10
10
years of professional experience

Work History

Lead Technical Automation Engineer

CSL Seqirus
12.2024 - Current
  • Currently supporting the migration of over 100 DeltaV Operate graphics to DeltaV Live, covering unit operations in buffer prep, chromatography, ultrafiltration, formulation, filling, and utilities.
  • Perform functional reviews by comparing the Live configurations against approved functional specifications, ensuring module bindings, parameter displays, and navigation structures are consistent and accurate.
  • Conduct testing sessions to simulate control workflows and validate real-time display behavior; capture and archive screenshots to support QA documentation and verification protocols.
  • Troubleshoot legacy discrepancies and unidentified modules by reviewing system scope and engaging with SMEs to confirm intended configuration.
  • Develop and implement HELP and overview screens to support operators with consistent navigation and contextual guidance across phases and production areas.
  • Participate in ongoing Phase III workstreams involving advanced process equipment, including microfluidizers, intensifiers, and portable formulation skids with no prior DeltaV Live references.

Automation Engineer Lead

GlaxoSmithKline, Rockville (Horizon Control Group)
03.2023 - 12.2024
  • Configured and tested over 45 DeltaV modules, including mixproof valves, EM instances, STATUS logic, and custom unit procedures across buffer prep and hold systems.
  • Designed complex control strategies from scratch to support over 30 new CIP, PAS, and transfer circuits, fully integrated with existing batch structures and recipe logic.
  • Developed and updated over 20 DeltaV Operate graphics, including detailed faceplates, valve arrays, and circuit overviews, ensuring functional alignment with module behavior and user interface standards.
  • Enhanced over10 phases logic with operator prompts and destination validation for manual transfer panels, addressing HAZOP recommendations and improving process safety.
  • Implemented clean hold status expiry logic across valve arrays and tanks, modifying STATUS modules, interlocks, and circuit parameters to align with GMP cleanroom protocols.
  • Authored and revised 15+ functional specification documents in Veeva Vault, ensuring traceability for new configurations and compliance with validation requirements.
  • Managed defect resolution, testing workflows, and deployment tracking through ServiceNow, with supporting documentation processed via TrackWise.
  • Supported validation execution in Kneat, reviewing test protocols and ensuring electronic records were complete and audit-ready.
  • Performed detailed simulation testing in the GSK manufacturing environment and participated in the full Factory Acceptance Test (FAT) process to verify functionality, alarm behavior, and batch execution prior to site deployment.

Global MES Integration Lead

Pfizer, Andover,MA (Cognizant)
07.2021 - 03.2023
  • Led the design, development, documentation, and implementation of MES integration, resulting 30% increase in productivity.
  • Designed, authored, developed, and configured EBRs recipe design in PharmaSuite, resulting in a significant reduction in input errors.
  • Managed medium-small teams and/or projects, resulting in successful project delivery within budget and timeline.
  • Worked closely with business management end users to strategically define needs and design solutions that add value, resulting in an improvement in EBR related processes.
  • Partnered with business clients and delivery teams to determine appropriate solutions, resulting in the successful implementation of MES Integration solutions.
  • Documented and analyzed the information needs of the business and ensured appropriate solutions were delivered, resulting in a reduction in system downtime.
  • Implemented global system guidelines for templatization.

Automation Engineer III

Sanofi Genzyme, Cambridge MA
06.2019 - 07.2021
  • Applied manufacturing process knowledge and automation engineering technical expertise to oversee execution, modifications, and related change controls for batch records.
  • Oversaw automation systems (MES/Syncade, DeltaV) functional specifications, ensuring consistent implementation of recipe modifications and changes, and adhering to governing documents related to change management.
  • Collaborated with Manufacturing, Digital Plant, IT, Validation, Quality, and MS&T to drive change initiatives to completion and facilitate timely migration to the production area.
  • Assumed responsibility for the lifecycle of electronic batch record changes. Worked with site functional teams, including manufacturing, engineering, warehouse, and quality assurance, to gather user requirements for recipe development.
  • Developed documentation to support MES recipe qualification, including test scripts and functional specifications.
  • Conducted testing of recipes in the development environment to ensure functionality. Managed the User Acceptance Testing process for recipe qualification. Provided technical support by troubleshooting problems related to DeltaV Explorer/Control Studio, RSLogix, Siemens S7-400/300, AB ControlLogix/PLC5/SLC500, FactoryTalk View Studio, iFix, OSI PI Historian, SQL Server.

QC/QA Specialist III

Takeda Pharmaceutical (DPS Engineering)
06.2018 - 06.2019
  • Provided budgetary and scheduling estimates for new system requirements of projects related to new and existing process equipment and control systems.
  • Generated all supporting documentation, including scope documents, approval slides, work orders, and protocols. Used project management skills to schedule, track progress, and make adjustments, while also providing solutions to complex reliability and operational problems.
  • Served as subject matter expert for Upstream and Downstream processes. Wrote and executed commissioning, validation, and qualification protocols for analytical equipment, generated final reports, and resolved protocol discrepancies and deviations.
  • Reviewed vendor-generated validation protocol packages, generated deviations, CAPAs, conducted root cause analysis, and assisted with deviation investigations. Participated in reviews and approvals of internal and external SOPs related to validation.
  • Evaluated new technologies for their application within a licensed GMP manufacturing facility, and programmed, configured, and integrated new equipment into an existing PCS and BMS. Developed, reviewed, and approved engineering standard practices through collaboration with partner departments.

Process Engineer III

Bristol-Myers Squibb
07.2017 - 06.2018
  • Supported implementation of Discoverant systems for Devens' commercial manufacturing processes following the given specifications, ensuring that the new system adheres to pharmaceutical cGMP by performing installation, operational, and performance/process qualifications.
  • Provided technical process expertise to the Information Systems team to support change controls, systematically collecting and analyzing the required changes and deviations, conducting impact analysis, reviewing, and approving tasks, routing notifications, and tracking the changes implemented.
  • Synchronized SAP systems in Syncade to guarantee better tracking and understanding of the quality status, vendor sources, and inventory batches in the change control process. Coordinated project activities with support from process engineers for successful implementation of the Discoverant system and supported the improvement of existing Discoverant hierarchies as required while actively participating in project meetings and support activities required by the GPS-IT team.
  • Utilized expertise and experience in one or several aspects of the design, control, and operation of large-scale inoculation, seed train, bioreactor, filtration, centrifugation, purification unit operations, cGMPs, automation systems, and DeltaV, working in both regulatory GMP and non-GMP environments to achieve team goal.

Associate Process Developer Engineer I

Immunogen, Inc
02.2017 - 07.2017
  • Helped validate and develop change controls in automation systems used in filtration, bioreactors, purification DeltaV, and Finesse equipment for both GMP and non-GMP environments by defining objectives, gathering information, defining procedures, drawing consequences, and proposals.
  • Created SOPs and training materials for DeltaV-Finesse equipment. Automated data flow from different sources to facilitate connecting and saving data from electronic batch records to other common applications such as Excel, SQL Server, Statistica, and JMP.
  • Created, supported, and maintained product dashboards and visualization tools for process monitoring and aggregation of data streams, making it easier to track any deviation.
  • Collaborated with subject matter experts in the process and analytical development areas to implement, support, maintain, and improve knowledge management databases/systems and data analysis.
  • Drove data management improvements through deployment of database architecture, automation of data aggregation, data queries, and data entry workflows.
  • Applied engineering and statistical principles to provide multivariate analysis (MVA) modeling for improved process understanding using Simca, JMP, and Statistica.

Automation Engineer I

Pfizer
11.2015 - 12.2016
  • Validated the transfer of electronic batch records to different databases to ensure compliance with cGMP requirements for change controls.
  • Created process configurations using the Statistica platform to simplify statistical analysis and process control monitoring for two Pfizer products: Coagulation Factor IX (Recombinant) and Pneumococcal conjugate vaccine.
  • Solved and escalated configuration issues.
  • Supported statistical process control and manufacturing engineering by configuring data analytics and informatics activities, which facilitated the handling of deviations and provided the required data to investigators for all CAPA and closure procedures.
  • Helped to develop a continuous process monitoring system and process monitoring control charts using Statistica.
  • Configured and implemented new Statistica functionalities to make overall processes faster and more efficient, including the respective validation documentation.
  • Wrote standard operating procedures (SOPs) to train users on the application and usage of the Statistica platform.

Production Chemist

SAFC Hitech
08.2015 - 11.2015
  • Monitored and adjusted plant equipment and chemistry to achieve the best results in high purity precursor production.
  • Performed and documented daily operational inspections and completed laboratory testing on various process streams to ensure high-quality precursor production.
  • Assisted the facilities team in plant maintenance and managed the procurement and inventory of materials critical to precursor production by working closely with vendor management systems like SAP and Oracle ERP.
  • Developed required operational reports and summaries and aligned the treatment schedule and strategy with production schedule modeling.

Education

Bachelor of Science - Nuclear Engineering Option

University of Massachusetts Lowell

Associate of Science - Engineering Science Transfer

Middlesex Community College

Skills

  • EBR Recipe Authoring – Emerson Syncade MES configuration for batch workflows, material tracking, and execution logic
  • Pharma MES Integration – Integration of Syncade with PAS-X, Opcenter PharmaSuite, and SAP in GMP-regulated environments
  • DeltaV Expert – Batch strategy design, CM/EM programming, phase logic, alarm handling, and Operate/Live graphics
  • DeltaV Upgrades – Experience upgrading DeltaV systems across multiple versions, including full migrations to DeltaV Live
  • System Integration – Configured interfaces between DeltaV, Syncade, OSI PI, SQL databases, and SAP for real-time data and production reporting
  • Data Platform Connectivity – Integrated automation systems with analytics tools such as Statistica, Discoverant, and custom reporting frameworks
  • Control Strategy Development – Converted functional specifications into validated automation solutions from scratch
  • Validation & Quality Collaboration – Supported FAT/SAT/IOQ activities and documentation with SMEs, QA, and validation teams using Veeva Vault and Kneat
  • GMP Compliance – Proficient in 21 CFR Part 11, GAMP5, and life sciences data integrity requirements
  • Technical Tools – Emerson DeltaV (Batch, Operate, Live), Syncade MES, OSI PI, Veeva Vault, ServiceNow, Kneat, SQL, OPC

Affiliations

  • American Chemical Society (UML ACS)
  • American Institute of Chemical Engineers (AIChE)
  • American Nuclear Society (ANS)

Timeline

Lead Technical Automation Engineer

CSL Seqirus
12.2024 - Current

Automation Engineer Lead

GlaxoSmithKline, Rockville (Horizon Control Group)
03.2023 - 12.2024

Global MES Integration Lead

Pfizer, Andover,MA (Cognizant)
07.2021 - 03.2023

Automation Engineer III

Sanofi Genzyme, Cambridge MA
06.2019 - 07.2021

QC/QA Specialist III

Takeda Pharmaceutical (DPS Engineering)
06.2018 - 06.2019

Process Engineer III

Bristol-Myers Squibb
07.2017 - 06.2018

Associate Process Developer Engineer I

Immunogen, Inc
02.2017 - 07.2017

Automation Engineer I

Pfizer
11.2015 - 12.2016

Production Chemist

SAFC Hitech
08.2015 - 11.2015

Associate of Science - Engineering Science Transfer

Middlesex Community College

Bachelor of Science - Nuclear Engineering Option

University of Massachusetts Lowell

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Julian Montoya-Zapata