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 Specialist, Technical Services engineer in this position within the Rota E2E will be 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 and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
- Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
- Provides technical support to manufacturing for complex problems and issues including process/equipment.
- Designs and conducts experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
- Authors and updates technical and manufacturing documents necessary for engineering studies, change control.
- Supports regulatory inspection activities for the facility
- Providing on-the-floor support of operational and technical (process/equipment) issues on the shop floor.
- Performing 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.
- Completing 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.
- Supporting team safety, environmental, and compliance objectives.
- Managing project and investigation timelines to ensure key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible.
- Collaborating effectively with the area Coaches, Operators/Mechanics, support groups, Quality, and Planning.
- B.S. Degree Preferably Engineering or Science
- Two (2) years post-bachelor's degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories.
- 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.
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
- Change Control author
- Deviation Management Investigator
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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