Darren Allen Jr.

Validation Engineer II at Societal™ CDMO (formerly Recro)
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Contact Information
us****@****om
(386) 825-5501

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Experience

    • Validation Engineer II
      • Jun 2021 - Present
    • United States
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Validation Engineer II
      • Jan 2018 - Jun 2021

      Create and coordinate approval of equipment qualification and cleaning validation protocols ensuring summary reports are in line with validation policies and procedures Troubleshoot validation related issues while executing the approved validation and qualification protocols Assist is cleaning validation remediation Produce cycle development protocols for automated cleaning processes Develop Standard Operating Procedures (SOPs) and Change Control Recommendations (CCRs)

    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Associate Engineer
      • Mar 2015 - Jan 2018

      ● Work at a CDMO to launch new solid dose drug products. Interface with customers to ensure quality and key deliverables are met in a timely yet economical fashion. ● Interfaces with key groups such as Engineering, Operations, and Quality to ensure new products are both robust and compliant. ● Apply my knowledge to troubleshoot, develop, validate, and optimize product development for scale-up to manufacturing. ● Experienced in various solid dosage manufacturing operations and operated equipment for granulation, coating, milling, blending and compression. ● Developed and performed regular cleaning, maintenance, and troubleshooting of all equipment. ● Generate and process purchase orders ● Create and edit Standard Operating Procedures (SOPs), Change Control Recommendations (CCRs), Installation, Performance, and Operational Qualifications (IQ/PQ/OQ). ● Followed cGMP processes and SOP’s and proper documentation

    • Estimator
      • May 2014 - Mar 2015
    • Student Volunteer Assistant Coach
      • Nov 2010 - Feb 2013
    • United States
    • Utilities
    • 1 - 100 Employee
    • Intern
      • Jun 2011 - Aug 2012

Education

  • Clarkson University
    Bachelor's degree, Chemical Engineering
    2009 - 2013

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