Validation Engineer

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Validation Engineer

  • Specialty:

    Engineering
  • Title:

    Validation Engineer
    • City:

      Fall River
    • State:

      MA
    • Zip Code:

      02720
  • Start date:

    10-03-2019
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    51036

Description

Validation Engineer
We are working with a Medical Device company in Fall River, MA who is looking for a Validation Engineer to work on a validation project. The Project is slated for 6+ months.

Responsibilities:

  • Document and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes
  • Creation of manufacturing work instructions
  • Interface with customers on technical issues, project timeline, and validation support
  • Actively participate on cross functional teams 
  • Provide support for operations and communicate with Program Managers
  • Provide training of operations personnel
  • Institute and apply best engineering practices to processes to facilitate high quality output and efficient throughput
  • Ensure effective use of designs, material, equipment and personnel throughout operations
  • Negotiate and administer facility engineering services, materials and equipment contracts as appropriate
  • Participate in the development and implementation of facility engineering technology and automation solutions to increase ecological sustainability and operational efficiency
  • Possess strong communication and interpersonal skills in order to build relationships with employees across the organization, including key client groups, peers, senior management, and subordinates
  • Ensure process validation program is robust, compliant and current
  • Develop and maintain re-validation program with risk-based approach


Qualifications:

  • 5-10 years Validation Engineering 
  • Experience in managing and executing projects
  • Strong interpersonal and organizational skills
  • Possess excellent leadership and project management skills
  • Ability to apply fundamental engineering principals to resolve issues relating to processing equipment and product launches 
  • Ability to apply working knowledge of applicable regulatory standards (FDA, ISO, OSHA, EPA, CFR, etc.) and good understanding in GMP requirements and validation processes
  • Must be able to prioritize critical versus non-critical issues and communicate to management

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