Aseptic Process Support Associate Director

6 months ago

Wellington City, New Zealand Merck Sharp & Dohme Full time

Animal Health Aseptic Process Support Program Lead for the Bendigo and Upper Hutt** manufacturing sites (Office location/role executed from : Upper Hutt, **New Zealand **)**
- Support the strategic development of the Global Animal Health Manufacturing (GAHM) Aseptic Process Support (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. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.

**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 to internal standards and (local) regulatory guidelines.
- Develop and Lead with other APS Associate Directors the Sterile Community of Practice within the GAHM network
- Provide investigation support in case of Media Simulation failure, Sterility failure and other Aseptic Process (AP)-related deviations.
- Provide hands on support in implementation of Aseptic Processing Policies and Standards
- Raising 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 AP 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 a/o 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. In addition, knowledge and expertise (with respect to start up and validation) in new utilities systems (like e.g. clean steam and WFI) is required.
- 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, process deviations, and contamination control. The incumbent must have demonstrated capability to guide contamination and AP-deviation investigations and lead the team to a proper problem solving approach (using standard work) including reporting and timely CAPA execution.
- Must also possess demonstrated interpersonal skills including leadership, coaching and development, performance management, motivation, communications and negotiations. This includes capability to train groups and other ways of knowledge transfer like Community of Practice.
- Must portray ability and experience to think at a global and strategic level and develop risk assessments, action plans, and position papers along with supporting rationale. Incumbent must be fluent in Enlish writing and verbal communication. Finally, incumbent must be able to communicate with Senior Site Management about strategy for the sites to establish a robust (aseptic) manufacturing environment.
- Extensive hands on experience in the development and enhancement of sterile standards within the manufacturing environment. In addition, knowledge of current and upcoming Annex 1 requirements and translation into GAHM standards for Aseptic Processes in Operations and Quality Operations is a clear need to operate in an EU-associated manufacturing environment.
- As two sites are being supported, must be able 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 disea

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