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Validation Engineer

Townsend & Associates McPherson, KS Contractor
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Validation Engineer


Responsibilities:

  • Report to the Validation Section Manager.
  • Assure that computerized systems are validated in accordance with cGMP principles, regulatory requirements, and company policies and standards.
  • Become a subject matter expert (SME) in Computer System Validation (CSV), provide technical expertise and guidance to management and cross functions.
  • Manage the validation of new systems, as well as changes to existing systems, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that CSV requirements are met.
  • Support all aspects of Computer System Validation projects
  • Author, execute, or review CSV documents: Validation Project Plans, User and Functional Requirements, Design Specifications, Risk Management tools, GxP and Electronic Records (ER) / Electronic Signature (ES) assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Enhanced Design Reviews, Final Reports, and Deviation Handling.
  • Manage and execute decommissioning activities.
  • Work collaboratively with cross functions within the organization.
  • Represent Validation in cross functional team meetings or projects as required.
  • Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.

Validation Engineer

Validation Engineer

W2 ONLY!!! NO CORP TO CORP

Qualifications:

  • Bachelor's degree in Engineering, Science, or related field.
  • 7+ year experience in a cGMP environment.
  • 3-5 years of direct computer system validation experience.
  • Strong understanding of GAMP 5 Risk Based approaches, GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for software IQ/OQ/PQ and Standard Operating Procedures.
  • Experience with JDE, SAP, empower is helpful.
  • Previous manufacturing cGMP, pharmaceutical or biotech experience is preferred.

Validation Engineer

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