Overview

Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsibilities

• Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE)
• Perform cleaning methods, such as wiping techniques of equipment, wall and ceiling moping and floor moping techniques.
• Able to operate and maintain equipment
• Understands the basic operations and functions of equipment and is able to perform basic troubleshooting
• Responsible for the cleaning/sanitization solution and material preparation
• Possesses basic technical knowledge and background in the industry
• Possesses basic and fundamental facility start-up experience
• Has participated in facility start-ups
• Assists with the execution of validation activities
• Responsible receiving and the organization of gowning and cleaning materials
• Identifies, communicates and resolves material discrepancies
• Understands aseptic technique concepts/proper cleanroom behavior
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and starts to understand 'why' behind the regulations
• Follows and executes Standard Operating Procedures (SOPs)
• Revises and authors simple SOPs
• Trains others on SOPs, equipment, all unit operations and non-manufacturing SOPs
• Participates and provides information 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 and participates in continuous improvement ideas
• Follow Proper cleaning/disinfecting schedules
• Identifies, suggests and seeks out for decision making
• Participates and supports regulatory inspections and client audits

Qualifications

• High School diploma and over 4 years of relevant experience or
• Associates'/Bachelor's (science preferred) degree with over 0 - 2 years of relevant or equivalent experience

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.