Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Andrew Maletta

Locust

Summary

Professional leader with extensive experience in driving strategic initiatives and fostering effective team collaboration. Strong background in project management, budget oversight, and stakeholder engagement, ensuring organizational goals are met efficiently. Known for adaptability, reliability, and focus on achieving impactful results. Skilled in leveraging data-driven insights, optimizing processes, and mentoring teams to excel in dynamic environments.

Overview

11
11
years of professional experience
1
1
Certification

Work History

Associate Director - Automation - Device Assembly and Packaging

Eli Lilly and Company
06.2023 - Current
  • Build process automation team, hiring team and assigning duties.
  • Deliver 4 Device Assembly Lines
  • Deliver 7 Packaging Lines
  • Deliver Central Palletizer to be utilized by all 7 Packaging Lines
  • Establish Automation Standards for Device Assembly and Packaging
  • Build Automation Technician organization supporting 24/7 operation
  • Deploy Service Now Change process for Concord to allow for business only/ non-quality impact change deployment for automation systems.
  • System Custodian for all Packaging lines and Serialization Systems.
  • Interim Maintenance and Engineering Associate Director effective 25JUL2025.
  • Leader of all automaton and process engineering as well as automation and maintenance technicians.
  • While in this role, 7 new production records were reached for 3 packaging lines and 2 reach assembly lines.
  • Create Continuous Improvement Roadmap for DAP
  • Leading Continuous Improvement efforts, ensuring growth completion, growth, and improvement for Device Assembly and Packaging.
  • Edit

Manager/ Team Lead Process Automation

Pfizer Inc
11.2022 - 06.2023
  • Team lead with 15 direct reports supporting 2 aseptic processing facilities, Liquids and Semi-Solids, Biological Operations, Packaging and Inspection, ECS, EMS, and HVAC.
  • Strategic planning for my department in regards to budget and resources/ resource loading for both 1 year short term and 3-5 year.
  • Responsible for coordinating with the site strategic planning team regarding future upgrade projects as well as new installations (both equipment and automation) to ensure there is a standard met across the site.
  • Point of contact between automation and EHS for site automation related EHS initiatives and improvements.
  • Leading team to standardize and modernize technical documents across facility.
  • Working with a team of senior leaders to facilitate the deployment of electronic batch record for the site.
  • Providing technical guidance to my team on issues outside of their understanding.
  • Leading a team focused on Data Integrity and Automation Contemporization
  • Edit

Manager, Automation Engineer - Vaccine

Pfizer Inc
05.2022 - 11.2022
  • Head of Automation and point of contact for all automation activities taking place in new mRNA Vaccine Formulation Facility (VFF/ Project Lightspeed), including Tangential Flow Filtration (TFF), Lipid Nanoparticle (LNP), Waste Removal, Clean In Place (CIP), and Preparation equipment.
  • Responsible for coordinating and leading a team of 350+ automation contract resources to upgrade, optimize, and support VFF.
  • In charge of reviewing all electrical drawings in regards to automation design, electrical design (Low voltage, networking, and medium voltage).
  • Coordinating with electricians, pipe fitters, and iron workers to ensure project was progressing.
  • Led the team in designing, procuring, and establishing areas of the facility to adhere to Class 1 Div 2 and ATEX standards to ensure safety concerns were met.
  • Continued support and expertise of VFF Mod 2 construction and startup.
  • Edit

Sr. Automation Engineer - COVID19 Vaccine

Pfizer Inc
02.2021 - 05.2022
  • Responsible for coordinating and leading a team of 100+ automation contract resources to design, install, commission, and validate a modular manufacturing facility including but not limited to: Electrical, HVAC, Process, SCADA, Qualified Utilities Design, and SAP Integration.
  • Equipment design and approvals for LNP, TFF, and CIP skids as well as Autoclaves and Parts Washers.
  • Designed and implemented the first SAP picture in picture deployment on a process SCADA terminal for operations ease of access.
  • Assisted in the drafting and review of 100+ Functional and Design specifications as well as 80+ Verification Tests consisting of 20,000+ steps.
  • Designed Vaccine Formulation Facility automation infrastructure including 60 PanelViews, 23 SCADA terminals, and 80 PLCs, spanning multiple networks.
  • Worked with compliance to provide all technical information for Data Integrity Assessments for new facility as well as leading the effort to upgrade equipment to remove DI gaps prior to implementation and qualification.
  • Established a standing, daily meeting with skilled trades to provide guidance to electricians and pipe fitters to be sure construction maintained schedule.
  • Supported CMOs as they implemented Vaccine manufacturing.
  • Worked with Global Engineering to ensure alignment between international vaccine production facilities as well as establishing working relationships.
  • Puurs Belgium BOLD MOVE! Semester 1 award nominee for cross site vaccine support.
  • Kalamazoo BOLD MOVE! Semester 1 award nominee for vaccine manufacturing project support excellence.
  • Assisted in schedule management for the vaccine project.
  • Continued support for vaccine filling operations.
  • Edit

Automation Engineer - COVID19 Vaccine

Pfizer Inc
09.2020 - 02.2021
  • Automation Lead for 10 contract engineers
  • Designed and implemented process improvements for the Lipid Nano Particle (LNP) equipment to increase efficiency and decrease process time for Vaccine Phase 1A operations.
  • Designed, implemented, and validated Tangential Flow Filtration (TFF) upgrades to double the output of the COVID19 vaccine to meet government requests including process changes and code authoring for Vaccine Phase 1A operation.
  • Edit

Automation Engineer

Pfizer Inc
02.2019 - 09.2020
  • Filling Support
  • Support for Heparin product transfer.
  • Covid-19 Vaccine vial format implementation.
  • Vial cap crimp vision support to increase false rejects below 1%.
  • Stopper transfer station equipment installation and verification.
  • Freeze Dry Support
  • Upgrade Wonderware InBatch to incorporate operator suggested fixes.
  • Crystal Reports upgrades to add additional content per quality and operator requests.
  • Prep Support
  • Vessel Tracking Solution designed and implemented to connect all site stopper units across 4 workcenters together to allow for shared data and improved process flow.
  • SICK Camera improvements for all Stopper Transfer Stations to improve vendor supplied software for docking repeatability and reliability.
  • Electronic signature implementation on PanelView Plus to meet 21 CFR Part 11 compliance. A job aid was also created for the team to do this as this was the first implementation on site to integrate a PV+ into a domain for authentication.
  • Team Support
  • Implemented procedural changes to streamline change control and decrease required equipment outages.
  • Trained colleagues within the Automation group regarding software capabilities.
  • Supported operations to further increase their understanding of the equipment that they use.
  • Created job aids to help others gain equipment knowledge as well pass along lessons learned and process improvement ideas.
  • Edit

Automation Engineer - Consultant

ThermalTech Engineering
02.2015 - 02.2019
  • Pharmaceutical and Food and Beverage Industries
  • Electrical design, PLC, SCADA, and Batch End Report (Crystal Reports) upgrades from Provox to Allen Bradley for multiple freeze dryers.
  • Created, installed, and tested Wonderware ArchestrA galaxies to host multiple pieces of equipment spanning multiple workcenters.
  • Managed engineering design, budget, and implementation for site wide upgrades of all Altec stopper loading, processing, and transferring over the course of two years, spanning multiple projects. Scope included Allen Bradley PLC software, Wonderware InTouch SCADA via ArchestrA galaxy, and Ethernet based Thin Client displays.
  • Microsoft SQL databases as well as stored procedures were designed and implemented with SQL Studio Reporting Services to generate production batch end reports.
  • Functional Specification documents were authored for all nine pieces of equipment as well as support for VT development and execution.
  • Frequent international travel on behalf of the client for Factory Acceptance Testing.
  • ThinManager configuration for a multi-workcenter control system from a single location.

Education

Bachelor of Science - Electrical Engineering

Western Michigan University
Kalamazoo, MI
12-2014

Skills

  • Project management
  • Strategic leadership
  • Analytical thinking
  • Coaching and mentoring
  • Technical implementation
  • Onboarding and training
  • Organizational development
  • Expense control

Certification

CEM - Certified Energy Manager

FS Eng (TÜV Rheinland) # 28479 / 24 - Machinery

Timeline

Associate Director - Automation - Device Assembly and Packaging

Eli Lilly and Company
06.2023 - Current

Manager/ Team Lead Process Automation

Pfizer Inc
11.2022 - 06.2023

Manager, Automation Engineer - Vaccine

Pfizer Inc
05.2022 - 11.2022

Sr. Automation Engineer - COVID19 Vaccine

Pfizer Inc
02.2021 - 05.2022

Automation Engineer - COVID19 Vaccine

Pfizer Inc
09.2020 - 02.2021

Automation Engineer

Pfizer Inc
02.2019 - 09.2020

Automation Engineer - Consultant

ThermalTech Engineering
02.2015 - 02.2019

Bachelor of Science - Electrical Engineering

Western Michigan University

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Andrew Maletta