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Validation Engineer - II - (Cleaning Validation/Sterilization)

Company:
LanceSoft INC
Location:
West Point, Pennsylvania, United States
Posted:
December 05, 2016
Description:

Qualifications:

•B.S./M.S. degree in an engineering/scientific field •Minimum of 4-8 years post-Bachelor’s degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry •Previous experience with equipment validation, specific experience with cleaning and sterilization validation required •Proven problem solving/ troubleshooting abilities •Working knowledge of Microsoft Office products, LIMs, and Trackwise •Strong technical writing and oral communication skills •Attention to detail is a must •Demonstrated ability to work both independently and as a part of a cross-functional team

Responsibilities:

•Primary responsibilities for the validation engineer include: -Day-to-day validation support to manufacturing operations including conducting equipment performance qualifications (specifically cleaning and sterilization validation) -Authoring validation protocols and final reports, executing validation studies, analysis of validation data -Resolving technical issues encountered during study execution -Providing Validation support of manufacturing investigations •This individual will be required to work in a cross-functional team and independently to accomplish validation objectives •Off-shift and weekend work may be required