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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Senior Specialist, West Point Technical Services is responsible for providing technical support to one of the manufacturing areas within the Rota E2E including Rotavirus Bulk, Formulation and Filling, and/or Packaging . Responsible for implementing continuous improvement projects as well as supporting equipment and investigations as required. Work as an individual contributor, team or project lead.
- Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
- Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
- Provides advanced technical support to manufacturing for complex problems and issues including process/equipment.
- Designs, conducts, and/or reviews and approves experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
- Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, change control.
- Supports regulatory inspection activities for the facility
- Provides on-the-floor support of complex operational and technical (process/equipment) issues.
- Performs and/or reviews and approves deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
- Performs and/or reviews and approves customer complaint investigations aimed to prevent complaint re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.
- Completes and/or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.
- Supports team safety, environmental, and compliance objectives.
- Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
- Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.
- B.S. Degree in Engineering or other equivalent technical field
- Four (4) years' post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
- Experience in deviation management and/or change control and/or equipment support and/or project support role.
- Highly developed communication, leadership and teamwork skills.
- Ability to manage projects/work to schedule/deadlines.
- Change Control author/reviewer
- Deviation Management investigator/reviewer
- Customer Complaint investigator/reviewer
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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