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principal validation engineer resume example with 10+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
  • :
Professional Summary

As a highly regarded Validation Engineer with over 10 years of GMP aseptic processing career experience, I have directly supported drug product, manufacturing operations in multi-product contract manufacturing organizations with authorship and execution of standard operating procedures, validation master plans/policies, protocols, batch records, deviations and CAPAs. My current position has been primarily focused on creation, implementation and maintenance of the aseptic processing simulation qualification program.

Skills
  • Knowledge of cGMPs and aseptic processing
  • Well-developed problem solving/investigative skills
  • Well-developed interpersonal and communication skills
  • Proficient in Microsoft Word, Excel and PowerPoint
  • Proficient in Track Wise
  • Regulatory Guidelines
  • Critical Thinking
  • New Product Introduction Strategies
Work History
Principal Validation Engineer, 10/2016 to Current
Amgen Inc.Seattle, WA,
  • Created and maintained aseptic processing simulation (aseptic media fills) qualification program for drug product and Small Scale Form Fill Finish (SSFFF) manufacturing areas, including media fill policy, batch records, summary reports and traceability matrices
  • Respected as a knowledgeable Subject Matter Expert (SME) for aseptic media fill program and process validation program, including supporting regulatory and client audits
  • Provided leadership support to other validation team members with project questions, documentation review and completion
  • Developed media fill strategy in alignment with regulatory agency expectations for the qualification of multiple new filling lines
  • Supported other departments cross functionally with various projects, such as process improvement activities
  • Continued listed associate responsibilities as described below.
Senior Validation Engineer, 09/2015 to 10/2016
PfizerGroton, MA,
  • Created and maintained aseptic processing simulation (aseptic media fills) qualification program for drug product and Small Scale Form Fill Finish (SSFFF) manufacturing areas, including media fill policy, batch records, summary reports and traceability matrices
  • Supported regulatory and client audits as a subject matter expert is aseptic simulation process and applicable process validation discussions
  • Created, reviewed, approved and maintained process validation master plans for drug product manufacturing
  • Authored, reviewed and approved process validation protocols and summary reports for drug product manufacturing
  • Authored, reviewed and approved supporting process protocols and summary reports, such as mixing studies, hold studies, etc
  • Authored, reviewed and approved component compatibility operational qualifications (CCOQs) and container closure integrity testing (CCIT)
  • Provided representation for Validation as a client representative/liaison on multiple client teams
Validation Engineer, 03/2014 to 09/2015
AptivEl Paso, TX,
  • Authored Process Performance Qualification documents and supports study execution.
  • Subject matter expert for the media fill program.
  • Managed execution of media fills and any updates to remain in a state of compliance with agency regulation.
  • Supports regulatory and client audits.
  • Represents validation during routine client meetings.
Validation Engineer, 08/2011 to 10/2013
AptivCarmel, IN,
  • Writing and executing IOPQ, Validation Plans, Validation Summary Reports, and Deviations for a variety of projects.
  • Develop and revise Standard operating procedures, rationales and controlled lists supporting the process simulation testing and container closure integrity testing programs.
  • Peer review of protocols and reports generated by co-workers.
  • Participated in internal and regulatory audits as the Subject Matter Expert for Container Closure Integrity Testing.
  • Developed and implemented redesigned Container Closure Integrity Testing program to ensure compliance with current regulatory requirements.
  • Assisted with facility restart as the Subject Matter Expert for Process Simulation Testing.
  • Assisted in the identification and implementation of process improvements for Process Simulation program through significant updates to process simulation testing documentation.
  • Trained manufacturing employees and supervisors on new standard operating procedures and protocols to be executed.
  • Completed Periodic Reviews for manufacturing equipment.
  • Active member of Remediation team focused on Sterility Assurance, tasked with identification of regulatory requirements, identification of gaps in the current process to the requirements, and develop a plan to address these gaps.
  • Interacted with various internal departments and external clients and vendors.
Education
Bachelor of Arts: Biology, Expected in 05/2003 to Hiram College - Hiram, OH
GPA:

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Resume Overview

School Attended

  • Hiram College

Job Titles Held:

  • Principal Validation Engineer
  • Senior Validation Engineer
  • Validation Engineer
  • Validation Engineer

Degrees

  • Bachelor of Arts

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