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 equipmentUnderstands the basic operations and functions of equipment and is able to perform basic troubleshootingResponsible for the cleaning/sanitization solution and material preparationPossesses basic technical knowledge and background in the industryPossesses basic and fundamental facility start-up experienceHas participated in facility start-upsAssists with the execution of validation activitiesResponsible receiving and the organization of gowning and cleaning materialsIdentifies, communicates and resolves material discrepanciesUnderstands aseptic technique concepts/proper cleanroom behaviorFollows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and starts to understand ‘why’ behind the regulationsFollows and executes Standard Operating Procedures (SOPs)Revises and authors simple SOPsTrains others on SOPs, equipment, all unit operations and non-manufacturing SOPsParticipates and provides information in the development of technical documents such as non-conforming events and deviationsPossess basic computer skills and able to efficiently use basic Microsoft applicationsSuggests and participates in continuous improvement ideasFollow Proper cleaning/disinfecting schedulesIdentifies, suggests and seeks out for decision makingParticipates and supports regulatory inspections and client audits Qualifications High School diploma and over 4 years of relevant experience orAssociates’/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.
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