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.
West Point Technical Services - VAQTA Integrated Product Team (IPT) is seeking highly motivated individuals to provide technical and equipment support for a vaccine manufacturing facility. This role will partner with Operations, Vaccine Manufacturing Science & Commercialization, Quality Operations, Bio-Sterile Validation and Regulatory groups to meet the targeted manufacturing and compliance initiatives for the VAQTA IPT.
This individual will be a subject matter expert on the technical support team for a licensed vaccine area with duties that include, but are not limited to: investigation and resolution of process/equipment deviations, ownership/management of the batch instructions, analysis of process-derived data to support trouble-shooting and process/equipment optimization, identification and implementation of process improvements, and support for regulatory inspections. Limited additional shift or weekend coverage may be required based on specific assignments.
The subject position will be responsible for the following:
- Process and process equipment support/troubleshooting, CR authoring, deviation investigation and continuing validation support.
- Collaboration across IPT functional areas to ensure robust processing, continuous improvement and cross-functional team building.
- Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.
- Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.
- Supporting team and IPT safety, environmental, and compliance objectives.
- Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
- Actively using and championing the use of Lean Six Sigma (LSS) and Merck Production System (MPS) tools, both in problem solving and day-to-day operational activities.
- Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
- BS/MS in chemical engineering, mechanical engineering, electrical engineering, biological sciences or related discipline with solid academic record and/or relevant work experience.
- Three (3) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 1 years).
- Highly developed communication, leadership, technical writing, and teamwork skills.
- Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role.
- Sterile manufacturing experience.
- Equipment selection and installation
- Deviation management
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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