Summary
Overview
Work History
Education
Skills
References
Affiliations
Accomplishments
Certification
References
Timeline
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MAKENZIE MACKIN

East Boston,MA

Summary

Dynamic Lead Life Science Engineer with proven expertise at Renovo Solutions, specializing in CAT I & II engineering and GXP compliance. Adept at driving team performance and achieving KPIs through effective communication and strategic training. Skilled in SOP writing and technical troubleshooting, ensuring high-quality standards in complex environments.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Lead Life Science Engineer

Renovo Solutions
08.2024 - Current
  • Lead a team of three-four engineers
  • Train engineers on both CAT I & CAT II equipment including HPLC's, balances, CTC PALS, incubators, centrifuges, and fridges
  • Ensure that my team meets monthly KPI's set by our client, Vertex Pharmaceuticals
  • Scrum and Weekly meetings to ensure alignment with our engineering team, OSS team, and Vertex's instrumentation team
  • Work with the Director of Service Delivery and Director of engineering to complete training plans and onboard new hires
  • Prioritize repairs, preventative maintenance, time and material, and regularly scheduled work
  • Communicate with end users and department heads to ensure clear scheduling and efficient time lines
  • Collaboration with our OSS team to ensure all work is done by either my engineering team or OEM is scheduled
  • GXP Trained
  • SOP Writing
  • CAT I & CAT II Engineering
  • Effective Communication
  • SME & Trainer
  • Digital Marketing
  • Quality Assurance
  • Manufacturing

CAT II Engineer

Renovo Solutions
01.2024 - 08.2024
  • Repairs and preventative maintenance on Agilent HPLC's, CTC autosamplers, AKTA HPLC's/UPLC's
  • Repairs and preventative maintenance on Incubators, balances, centrifuges, and freezers
  • Complete and close all work orders, while working both Nuvolo and Renovo Live platforms
  • GXP trained and trainer
  • Part Source Trained
  • Work and troubleshoot with teammates and OEM
  • Maintain and schedule workload to meet KPI's

Field Service Engineer

Molecular Devices
04.2022 - 12.2023
  • Execute and complete repairs, GXP/GMP validation hardware and software validations on plate readers, fluidics models, cell imagers, and automation modules
  • Communicate efficiently and schedule appointments with client
  • On-site validation execution, validation training, and trained in executed over 7 software validations
  • Execute and file qualification/validation paperwork and service reports
  • Create quotes and PO's
  • Use service manuals to perform onsite diagnostics
  • Timely repairs, validations, and paperwork
  • Constant stream of communication with customer and their teams
  • Great communication skills, an expansive of knowledge of GMP and GXP protocols and practices
  • Executed and completed over 300 onsite GxP/GMP hardware validations and 8 software validations in a year and a half, while maintaining and hitting all KPI's, cost goals, and successfully training new team members

Quality Technologist

Downeast Cider
04.2021 - 04.2022
  • GMP proficient in laboratory and on manufacturing floor
  • CIP (Clean in Place) and SIP (Sanitize in Place) all fermentors and brite tanks
  • Execute, write, read and implement in-house SOP's for quality lab and manufacturing floor
  • Assist in running our quality department by performing essential functions including plating samples, making agar, reading our aerobic and anaerobic plates, assist in running quality panels for customers and in house employees
  • Reorganize and implement our can library for historical data and batch tracking
  • Advanced knowledge of fermentation cultivation, pitching, plating, and generational yeast

Education

Life Sciences Phase I -

College of Biomedical Equipment Technology
01.2024

Life Sciences Phase II -

College of Biomedical Equipment Technology
01.2024

Bachelor's - Health Science

University of Southern Maine
01.2017

Skills

  • Team Leader
  • Cross Functional Teamwork
  • GXP Trained
  • SOP Writing
  • CAT I & CAT II Engineering
  • Effective Communication
  • SME & Trainer
  • Digital Marketing
  • Quality Assurance
  • Manufacturing
  • Medical Device Trained
  • Lab Instrumentation
  • Production
  • Asset Management
  • Contracts and Budget
  • Quality assurance
  • Team leadership
  • Project management
  • Technical troubleshooting
  • GXP compliance
  • SOP writing
  • Preventative maintenance
  • Equipment maintenance
  • Work order management
  • Teamwork and collaboration
  • Technical documentation
  • Continuous improvement
  • Engineering documentation
  • Machine learning

References

Luigi DiSisto, Molecular Devices, 781-844-9821, luigid68918@yahoo.com

Affiliations

  • Volunteer camp counselor for Crohn's and Colitis Foundation.
  • Volunteer at Crohn's and Colitis Events.
  • Volunteer at Lynn Police Christmas Party.
  • Service award for Molecular Devices.

Accomplishments

  • Service Award for Molecular Devices.
  • Published my first book in 2025.
  • CBET Cat I and CAT II Certificates.

Certification

  • CBET CAT II
  • CBET CAT I
  • HAZWOPER
  • World Beer Technology

References

References available upon request.

Timeline

Lead Life Science Engineer

Renovo Solutions
08.2024 - Current

CAT II Engineer

Renovo Solutions
01.2024 - 08.2024

Field Service Engineer

Molecular Devices
04.2022 - 12.2023

Quality Technologist

Downeast Cider
04.2021 - 04.2022

Life Sciences Phase I -

College of Biomedical Equipment Technology

Life Sciences Phase II -

College of Biomedical Equipment Technology

Bachelor's - Health Science

University of Southern Maine

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MAKENZIE MACKIN