Description:

 

Responsible for the planning and coordination of validation studies, for conducting and documenting validation studies according to written protocols, and processing and submitting data in final validation reports.

 

Duties:

Develops validation protocols for equipment, facilities, processes, and cleaning procedures. Plans and schedules validation activities. Performs validation studies per schedule and written protocols. Accurately accumulates, documents, and communicates data. Prepares and submits validation final reports. Understands and assures conformance to cGMPs, SOPs and sound scientific principles. Recognizes, recommends, evaluates, and implements steps to improve procedures, SOPs, and products. Performs other quality assurance functions, including but not limited to: auditing, failure analysis, and process control/ monitoring. Responsible for a variety of quality assurance activities including: shipment release, completed batch record review, deviation program, and other duties as assigned.

 

Requirements:

B.S. degree in Chemical Engineering or related field.   Proficient in the use of computers and MS Office products. Able to work effectively both as an individual and as a team member.