OverviewResponsible 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 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.Need help finding the right job?We can recommend jobs specifically for you!
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability (https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&iniframe=1&hashed=-435740542)Job Locations US-PA-Philadelphia
