Associate director Operations

3 weeks ago

Upper Hutt, New Zealand Merck Gruppe - MSD Sharp & Dohme Full time

Job Description

  • 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. 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 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 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 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 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 (in particular proven capability to train groups and other ways of knowledge transfer like CoP), including leadership, coaching and development, performance management, motivation, communications and negotiations.

  • 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 diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/5/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID: R299257

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