Summary
Overview
Work History
Skills
Accomplishments
Timeline
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Eric Merrell

Imperial

Summary

Dynamic Validation Manager with a proven track record at Ellab Validation & Monitoring Solutions, excelling in regulatory compliance and team leadership. Expert in project planning and conflict resolution, I foster strong partnerships and drive performance improvements, ensuring adherence to industry standards while enhancing customer loyalty and satisfaction.

Overview

16
16
years of professional experience

Work History

Regional Validation Manager

Ellab Validation & Monitoring Solutions
12.2020 - Current
  • Maximized performance by monitoring daily activities and mentoring team members.
  • Developed and maintained relationships with customers through account development.
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Leveraged industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.

Sr. Validation Engineer

MilliporeSigma
08.2020 - 12.2020
  • Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
  • Drove global Standard Operating Procedure (SOP) harmonization, incorporating input from local teams across the globe to standardize work instructions.


Validation Engineer II

Curium Pharmaceuticals
04.2018 - 08.2020
  • Authored validation protocols for manufacturing systems including autoclaves, depyrogenation ovens, VHP sterilization, SIP, CIP, Cleaning and Process Verifications verifying compliance with internal and industry guidelines including PDA, ISPE, WHO and EudraLex.
  • Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
  • Trained and assisted staff in validation techniques, methods and testing processes.
  • Identified causes of equipment failures and made suggestions for issue resolution.

CQV Engineer

PSC Biotech
05.2017 - 04.2018
  • Collaborated with multi-disciplinary team to Commission and Qualify two new autoclaves for the Microbiology department, including FAT and SAT.
  • Planned and executed plant shutdown activities, drove projects to completion to meet internal customer timelines and return areas/systems to production.



Validation Engineer II

Pfizer/Meridian Medical Technologies
12.2015 - 05.2017
  • Author and execute Validation protocols (IQ, OQ, PQ, RQ) for on-site sterilization and depyrogenation equipment.
  • Served as Quality Observer (QO) for site Media Fill Program.
  • Performed Period Review of manufacturing systems and equipment.


Validation Engineer

Patheon
12.2014 - 12.2015
  • Author and execute validation protocols.
  • Author Quality Risk Assessment (QRA) of existing autoclave loads to proposed loads to determine need for Performance Qualification.


Validation Technologist

Mallinckrodt
03.2009 - 12.2014
  • Perform routine re-qualifications of plant manufacturing equipment including but not limited to CTUs, autoclaves, ovens, lyophilizers, isolators, vials washers and fillers.
  • Perform Periodic Review of plant systems, equipment and processes.

Skills

  • Regulatory compliance
  • Partnership development
  • Project planning
  • Staff development
  • Cross-functional teamwork
  • Key performance indicators
  • Decision-making
  • Relationship building
  • Change management
  • Team leadership
  • Conflict resolution

Accomplishments

Led team of 6-8 Validation Engineers at biologics site in Boulder, Colorado in Steam-in-Place (SIP) effort. Site was brought back into production after being in idle state in excess of 2 years. Conducted risk assessment and mentored team in SIP and steam sterilization principles.

Timeline

Regional Validation Manager

Ellab Validation & Monitoring Solutions
12.2020 - Current

Sr. Validation Engineer

MilliporeSigma
08.2020 - 12.2020

Validation Engineer II

Curium Pharmaceuticals
04.2018 - 08.2020

CQV Engineer

PSC Biotech
05.2017 - 04.2018

Validation Engineer II

Pfizer/Meridian Medical Technologies
12.2015 - 05.2017

Validation Engineer

Patheon
12.2014 - 12.2015

Validation Technologist

Mallinckrodt
03.2009 - 12.2014
Eric Merrell