Senior Specialist, Engineering - Technical Services (VAQTA )
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 lead a technical support team 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 deviations, ownership/management of the batch instructions, analysis of process-derived data to support trouble-shooting and process optimization, identification and implementation of process improvements, support for regulatory inspections and submissions and implementation of process analytical technologies. Limited additional shift or weekend coverage may be required based on specific assignments.
The subject position will be responsible for the following:
- Lead a team providing technical support for the bulk vaccine manufacturing facility. Team responsibilities may include 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.
- Adapts and implements departmental plans and priorities based on department and site scorecard to address local business, service and operational challenges.
- Mentors and coaches staff within the organization. Uses feedback to improve self and others, and to ensure that customer/stakeholder needs are the cornerstone of decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems.
Education Minimum Requirement:
- BS or MS degree in chemical engineering, biological sciences or related discipline
Required Experience and Skills:
- Minimum 5 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations - OR - a M.S. degree plus 3 years experience in GMP manufacturing and/or technical support of GMP manufacturing operations - OR - a PhD degree
- Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role.
- Minimum 2 years of experience in vaccine manufacturing process development or scale-up
Preferred Experience and Skills:
- Highly developed communication, leadership and teamwork skills.
- Experience leading departmental or cross-functional teams.
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Job: Chemical Engineering
Employee Status: Regular
Number of Openings:
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Company Trade Name: Merck