This position is a specialist role with responsibility for providing aseptic technique training for Operations, Engineering/Maintenance, Quality Systems, and PTS personnel. The primary emphasis will be on successfully preparing employees for Gown Qualification and Aseptic Certification Status and ensuring they are current. The Aseptic Technique Manufacturing Training Specialist works closely with Microbiology and the Learning & Development staff to ensure that all training requirements are met and properly documented.
Create and execute training program for aseptic technique of personnel involved in the manufacturing of products in controlled environments (Filling operators, Mechanics, Compounders, etc.) Perform audits of personnel behavior within the clean room and apply corrective actions as needed Participate in internal audits and work alongside Manufacturing and Quality management to ensure commitments are accomplished in a timely manner Observe processes in the clean room and continually seek process improvement for quality and process efficiency Schedule and provide periodic and remedial training on aseptic technique/practices and gowning procedures In coordination with the Learning & Development team, select or develop teaching aids such as training handbooks, demonstration models, multimedia visual aids, computer tutorials, and reference works. Assess trainees to measure progress and to evaluate effectiveness of training. Report to departmental management on progress of employees under guidance during training periods. Assist employees with problems concerning \"how to\" perform specific tasks related to their duties as outlined in procedures and batch records. Assist Learning & Development Director to analyze, design, develop, and implement Sterile Operations learning strategy. Assist with the revision of existing training and support materials as necessary to reflect the needs of the audience and the organization. Monitor methods used by employees in their daily duties and make improvement recommendations. Mentor Gown Qualified Operators and other personnel. Develop strong relationships with all departments to encourage training and development behaviors Maintain professional, courteous, and effective communication with all co-workers, customers, and contractors in the execution of all job functions. Perform job responsibilities in a safe and efficient manner, maintaining a clean work environment. Complete additional duties and projects as necessary. Assist supervisors and managers in all other duties as assigned.
Bachelor's degree in a Natural Science with a minimum of 5 years of relevant pharmaceutical industry experience or equivalent combination of education and experience required. Aseptic manufacturing experience required. Associated topics: bioengineer, design, develop, engineer, manufacturing, manufacturing engineer, mechanical, mechanical engineer, process engineer