Animal Health Aseptic Process Support Program Lead based in New Zealand, supporting the Upper Hutt (NZ) and Bendigo (Australia) manufacturing sites.
Support the strategic development of the Global Animal Health Manufacturing (GAHM) Aseptic Process Solutions (APS) program and provide hands-on implementation support for the indicated manufacturing sites.
Deployment of resources across the GAHM network to support successful implementation and sustainability of the APS Program.
Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.
What will you do: Provide tactical leadership in the development, implementation, and maintenance of aseptic practices within the above-mentioned part of the GAHM network.Establish and direct deployment/implementation of proactive measures across above-mentioned GAHM Sterile facilities to enhance and sustain aseptic programs.Partner with Animal and Human Health Sterile Councils to ensure compliance with internal standards and (local) regulatory guidelines.Develop and Lead with other APS ADs the Sterile Community of Practice within the GAHM network.Provide investigation support in case of Media Simulation failure, Sterility failure, and other Aseptic Process-related deviations.Provide hands-on support in the implementation of Aseptic Processing Policies and Standards.Raise the level of Aseptic Robustness across indicated part of the GAHM Network in areas of identified weakness (Technology, Operator Training, Engineering Design, etc).Interact closely with Site Management teams (in particular operations, quality operations, and support functions like e.g. maintenance and BTS) to support establishment and sustaining of procedures and practices allowing for a robust manufacturing process meeting relevant Aseptic Process standards in Bendigo and Upper Hutt sites.What should you have: Bachelor of Science degree in microbiology, engineering, or a related discipline.Minimum 5-10 years' experience in the Manufacturing Industry, working in sterile environments with a strong background in microbiology and sterile process equipment design and/or biological production process development and execution.Extensive hands-on experience in the development of aseptic programs including Media simulations, Smoke studies, Clean Room Qualification, Steam-in-Place validation, and Environmental Monitoring. Knowledge and expertise (with respect to start-up and validation) in new utilities systems (like e.g. clean steam and WFI) is required.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, process deviations, and contamination control.Demonstrated interpersonal skills, including leadership, coaching and development, performance management, motivation, communications, and negotiations.Ability and experience to think at a global and strategic level and develop risk assessments, action plans, and position papers along with supporting rationale. Must be fluent in English writing and verbal communication.Extensive hands-on experience in the development and enhancement of sterile standards within the manufacturing environment. Knowledge of current and upcoming Annex 1 requirements and translation into GAHM standards for Aseptic Processes in Operations and Quality Operations is necessary.Ability to travel 25-50% of working time.Who we are: We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.
What we look for: Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity.
Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
Employee Status: Regular
Travel Requirements: Flexible Work Arrangements: Not Applicable
Job Posting End Date: 01/5/2025
Requisition ID: R299257
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