Specialist, Engineering, VAQTA Technical Service
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
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, electircal engineering, biological sciences or related discipline with solid academic record and/or relevant work experience.
- Minimum 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
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Chemical Engineering
Employee Status: Regular
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Company Trade Name: Merck