Merck & Co Hiring for Aseptic Process Support Associate Director job in Millsboro Full Time

• Animal Health Aseptic Process Support Program Lead for the Bendigo and Upper Hutt manufacturing sites (Office location: Upper Hutt)
• 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.
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– 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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. – All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. – For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. -This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R261887