Title:  Validation Engineer

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.