Validation Engineer

  • Date Posted February 16, 2021
  • Location Leetsdale, Pennsylvania
  • Job Type Direct
  • Job ID 17219

Validation Engineer

Our global medical device client who is committed to transforming the practice of blood management globally is looking for a validation engineer for their Pittsburgh operation.

The candidate would be responsible for driving the quality performance and compliance by defining, implementing and maintaining the validation program as well as oversight to lead validation and controls for contract manufacturers on a global basis to meet FDA and ISO requirements. Additional responsibilities include participating in  manufacturing programs, product realization, and ensuring projects meet the regulatory requirements of the company and customer quality systems.

Essential Duties:

  • Analyze and summarize the results of various qualification activities using valid statistical practices within the Engineering Quality System.
  • Assist or lead in the creation and qualification of test methods, DOE’s and other activities that determine the systematic suitability of a product.
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, and process controls infrastructure for critical sustaining parts and new products.
  • Develop and execute IQ, OQ and PQ protocols to ensure compliance with the Engineering Quality System and customer requirements for product, processes, facilities, software and equipment within the facility and / or contract manufacturer.
  • Develop and execute the Validation Master Plan, covering internal and external operations and key processes.
  • Develop and execute Validation programs for internal and external operations.
  • Other tasks as required by management or as needed to support business continuity
  • Participate in cross-functional teams as needed to transfer products between Plants or to contract manufacturers and to implement or execute programs and that will assist with those transfers.
  • Participate in cross-functional teams as needed to transfer products from development to production and to implement or execute programs and activities that will assist in the development or improvement of products and – processes.
  • Review documentation, manufacturing practices, engineering change orders, and procedure changes for quality requirements and compliance with the engineering quality system.
  • Review existing validation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
  • Support project teams to assist the qualification of process changes.
  • Train and coach local plant validation resources in order to ensure knowledge transfer, understanding and timely V+V activities.

Experience:

  • 3yrs: Related experience in the medical device industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods

 

 

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