Validation Specialist II

Swiftwater, PA

Posted: 07/05/2019 Industry: Biotech/R&D/Science Job Number: 49217


Responsibilities include but are not limited to the following:
  • Performing Instrument installation qualification
  • Performing Instrument operation qualification
  • Performing Instrument performance qualification
  • Writing cGMP protocols and reports for instrument qualification
  • Writing cGMP procedures for operation of instruments
  • Writing preventive maintenance plans for new instrumentation
  • Writing user requirement specifications
  • Initiating and leading change controls for implementation of new instrumentation

  • The individual must have 5 years industry experience with 2 years’ experience in instrument qualification.  It is preferred if the individual had 10 years industry experience with 5 years’ experience in instrument qualification.
  • The individual will be responsible for instrument qualification - including installation qualification, operation qualification, and performance qualification of analytical instrumentation and software in Quality Control laboratories.  The individual will also be responsible for authoring cGMP protocols, reports, equipment operation instructions, user requirements specifications, and preventive maintenance plans.
  • Strength in several LEAD Competencies which include - Think Strategically, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions.

  • The individual must have a bachelor’ s degree in engineering or science related field.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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