Validation Manager

in Levittown, PA

Job #:535439

Practice Area: IT

Date Posted: 10/28/2020

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The Validation and Tech. Transfer Manager is responsible for managing all aspects of the validation program/team. This includes equipment qualification, process evaluation and process validation, cleaning validation and technology transfer.  Works under limited supervision to provide technical guidance and managerial support to the validation team and provides a risk-based approach to validation activities in support of regulatory requirements.

Essential Duties and Responsibilities:

  • Manage the equipment/facilities qualification program
  • Manage the process validation program
  • Manage the cleaning validation program
  • Manage the technology transfer function
  • Ensure the validation department staff is appropriately trained in cGMP’s and company policies and procedures related to their responsibilities
  • Prepare and maintain status reports to advise management of the validation status for the facility
  • Maintain a risk-based validation program which is compliant with regulatory standards
  • Maintains revalidation schedules ensuring the facility remains in a validated state.
  • Writes and reviews SOP’s related to qualification/validation/mapping activities.
  • Works closely with cross-functional departments as necessary to resolve issues
  • Performs other duties as assigned

 

Qualifications:

  • Bachelor Degree / Engineering, Pharmaceutical educational background, Master’s Degree preferred
  • Thorough understanding of cGMP environment
  • Administration:  Excellent written and verbal presentation skills, documentation accuracy.
  • Computer:  Word processing, e.g. Microsoft Word, spreadsheet databases e.g. Excel, electronic communication systems e.g. Microsoft Outlook, business management systems e.g. CMS.
  • Windows applications, MS Office (Word, Excel, Outlook), SAP, ERP platforms and Track wise
  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

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