What will you do?

• Prepare and process equipment and materials for manufacturing use including performing equipment functional checks, start up, basic maintenance and operation of single use bioreactors, purification columns and skids.
• Perform equipment function checks, preventative maintenance, standardization and calibration, and testing of in-process samples using analytical equipment following written procedures. Clean production cleanrooms and remove waste materials.
• Use and Navigate with moderate understanding manufacturing systems for process operation and process performance Associate II must be able to independently train junior associates on VVS policies, programs and procedures commensurate with their experience as a qualified trainer.
• Reviews departmental documentation (e.g., Standard Operating Procedures, PBR’s), data, and trends. Participates in revisions, providing input, as necessary.
• Participates in the investigation of non-conformances in compliance with quality procedures, policies and regulations. Participate in innovation and continuous improvement activities.

Bachelor's degree in life sciences preferred, comparable experience accepted

High school diploma required

Experience

• 1-3 years’ industry related experience with a Bachelor’s Degree in Life Sciences
• 2-4 years’ industry related experience with a Associates Degree/certificate program
• 3-5 years industry related experience with a high school diploma
• Strong interpersonal and communications skills; written and oral.
• Solid understanding of applicable regulatory requirements

• Make decisions for moderately complex GMP manufacturing activities including process performance with minimal to moderate supervision.
• Recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior operators or area management.
• Provide effective written or verbal communication to peers, senior associates, and area management within their operational group.
• Understand operational documents for GMP compliance, accuracy and completeness.
• Safely perform activities on the shift in order to prevent releases, accidents and injuries.

• While performing the duties of this job, the employee:
• Needs Ability to aseptically gown and/or sterile gown as needed
• Ability to work within environmental clean rooms
• Ability to function in a dynamic environment and balance multiple priorities simultaneously
• While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time.
• Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Is regularly required to talk and hear
• The employee frequently is required to sit and stand for extended periods.
• The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.