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Sr Specialist, Aseptic Process Support

Requisition ID: QUA008252 Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. Providing tactical leadership in the development, implementation, and maintenance of aseptic practices within the Animal Health network  Establish and direct deployment/implementation of proactive measures across MMD Animal Health Sterile facilities to enhance and sustain aseptic programs Ensure compliance to internal standards and regulatory guidelines Develop and Lead with other AD's the Sterile Community 'Forum' within the Animal Health network  Provide Media Simulation and Sterility Failures Investigation support Provide hands on support in implementation of Aseptic Processing Policies and Standards Raising the level of Aseptic Robustness across US Midwest region in areas of identified weakness (technology, Operator Training, Engineering Design, Single use disposables, Qualification, Cleaning disinfection, gowning EM programs etc) Qualifications Education Minimum Requirement: Bachelor of Science degree in microbiology or related discipline Required Experience and Skills: Minimum 10 years experience in the Manufacturing Industry working in sterile environments with background in microbiology and sterile process equipment design. Extensive hands on experience in the development of aseptic programs include media simulation, smoke studies, Clean Room Qualification, Steam-in-Place validation, Environmental Monitoring,etc Incumbent must possess strong analytical, problem solving, and technical writing skills required to provide Quality, microbiological and technical expertise for sterility assurance investigations related to media challenge/sterility failures, product deviations, and contamination control. Must also possess demonstrated interpersonal skills, including leadership, coaching and development, performance management, motivation, communications and negotiations. Preferred Experience and Skills: Use of Six Sigma and LeanSix Sigma tools Green or Black Belt certification strongly desired Pharmaceutical Experience in a operations or aseptic technical support leadership position Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life. ID: QUA008252
Salary Range: NA
Minimum Qualification
11 - 15 years

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