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Validation Specialist II
Ref No.: 15-04182
Location: Swiftwater,, Pennsylvania
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

Skills: 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 Bachelors degree in engineering or science related field.