Overview

Responsible for providing supervision in the cleaning and sanitization of GMP space and associated areas that manufacture Master and Working Cell Banks, within production facilities that manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

This is a night shift opportunity. The hours are 4:00pm - 2:30am.

Responsibilities
• Supervises, leads and oversees performance of associates in area of responsibility
• Understands aseptic technique concepts and impact of the cleaning/sanitization program has on the GMP environment
• Prepares and adjusts schedules, delegates and is accountable for area of responsibility
• Trains, coaches and mentors associates within area of responsibility
• Oversees the operation and maintenance of cleaning equipment
• Oversees cleaning/sanitization solution and material preparation
• Possess basic technical knowledge and background
• Oversees the ordering, receipt, organization and inventory of cleaning/sanitization and gowning materials
• Identifies and communicates material discrepancies
• Understands the concept of manufacturing processes and methods
• Oversees compliance to regulatory requirements and current Good Manufacturing Practices (cGMPs) of operations within scope of responsibility
• Understands regulatory requirements and cGMPs within scope of responsibility and is able to communicate gaps, coach and mentor others
• Addresses and improve complex compliance regulatory gaps/issues
• Oversees execution of, follows and executes Standard Operating Procedures (SOPs)
• Oversees execution of, follows and executes Batch Records (BRs)
• Participates in the development of technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates, implements and leads continuous improvement efforts
• Leads complex technical problem solving in area of responsibility
• Makes complex decisions in area of responsibility
• Participates on regulatory inspections and client audits
• Regularly interacts, coordinates, and deals with problems in a cross functional manner with groups that support manufacturing and area of responsibility
• Cross trains in other areas and may be utilized to perform above job functions across the entire siteAccomplishes staff results by communicating updated organizational information, job expectations & supporting their work

Qualifications
• HS Diploma or equivalent required and
• 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
• BS/BA in Science related field preferred; or combination of relevant Experience & Education

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.