Qualifications:
B.S./M.S. degree in an engineering/scientific field. Minimum of 8+ years post-Bachelors degree in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry. Previous experience with cleaning and sterilization validation required. Proven problem solving/ troubleshooting abilities •Working knowledge of Microsoft Office product, 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, and analysis of validation data -Resolving technical issues encountered during study execution -Providing validation support to 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
B.S./M.S. degree in an engineering/scientific field. Minimum of 8+ years post-Bachelors degree in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry. Previous experience with cleaning and sterilization validation required. Proven problem solving/ troubleshooting abilities •Working knowledge of Microsoft Office product, 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, and analysis of validation data -Resolving technical issues encountered during study execution -Providing validation support to 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