LabTemps is searching for a Validation SME for our client in Albany, NY for a 3 month contract.

  • The Subject Matter Expert in Validations would have the following responsibilities:
  • This role requires independent validation execution responsibilities, to optimize site validation strategy and mentor validation specialists on site
  • Manage cleaning, process and equipment validation activities throughout the plant with minimal guidance. This includes managing, coordinating and executing validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC.
  • Establish and implement validation procedures and appropriate documentation to support installation, operational, cleaning and performance testing
  • Maintain awareness of current regulatory trends and practices. Assist in FDA and customer audits.
  • Develop, review and approve validation protocols and all completed validation documentation. Authorize equipment for use and product release.
  • Periodic review of Site Validation Master Plan to update quarterly.
  • Redesign and implement documentation and procedures in order to increase efficiency and reduce manual inputs, while maintaining regulatory requirements.
  • Develop templates for various validation execution activities.
  • Mentor validation team members, provide training on validation issues and documentation.
  • Manage Quality Assurance initiatives plant-wide as they impact validation.
  • Track all validation documentation throughout the plant and follow-up as needed.
  • Perform other quality functions as necessary or as requested. Perform other duties as may be reasonably assigned in the course of business.
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Validation SME | Contract

Albany, NY

LabTemps is searching for a Validation SME for our client in Albany, NY for a 3 month contract.

  • The Subject Matter Expert in Validations would have the following responsibilities:
  • This role requires independent validation execution responsibilities, to optimize site validation strategy and mentor validation specialists on site
  • Manage cleaning, process and equipment validation activities throughout the plant with minimal guidance. This includes managing, coordinating and executing validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC.
  • Establish and implement validation procedures and appropriate documentation to support installation, operational, cleaning and performance testing
  • Maintain awareness of current regulatory trends and practices. Assist in FDA and customer audits.
  • Develop, review and approve validation protocols and all completed validation documentation. Authorize equipment for use and product release.
  • Periodic review of Site Validation Master Plan to update quarterly.
  • Redesign and implement documentation and procedures in order to increase efficiency and reduce manual inputs, while maintaining regulatory requirements.
  • Develop templates for various validation execution activities.
  • Mentor validation team members, provide training on validation issues and documentation.
  • Manage Quality Assurance initiatives plant-wide as they impact validation.
  • Track all validation documentation throughout the plant and follow-up as needed.
  • Perform other quality functions as necessary or as requested. Perform other duties as may be reasonably assigned in the course of business.

Learn More:

Mick Parks

Business Development Rep

mickparks@messinagroupinc.com

(847) 692-0614

Send email View LinkedIn

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