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Senior Specialist, Project Engineer - Bulk Manufacturing

Requisition ID: PRO018799 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.  Key vaccine product franchises are experiencing significant growth requiring staffing. This is a rotational assignment as the candidate will initially be assigned to technical operations at the West Point site within vaccine bulk processing and will then transition to a full time assignment to support active capital projects to increase vaccine bulk manufacturing capabilities. The Sr. Specialist, Technical Services in the BioBacterial Manufacturing End-to-End provides engineering technical support to the manufacture of liquid vaccines while actively supporting, participating in, and embracing an empowered team culture. In this role, the Sr Specialist will work as an individual contributor as well as a team or project lead to lead work of others as required. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions.  Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. Additional responsibilities include: Responsible for defining and leading projects. Specifically, will use standard project management approaches and assemble and lead teams in the execution of projects with responsibility for resourcing, charter development, project planning and tracking, risk management,and escalation. The incumbent will operate with a high degree of independence, assuring alignment with appropriate functional leaders and stakeholders while advancing their assigned projects and initiatives. The incumbent will have interest and capability in rigorous scientific approaches, operational excellence methods, systems development and change execution management, and strong analtyical, communication and interpersonal skills. Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements. Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts.  Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.  Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.  Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.  Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.  Develop and assures consistent application of standardized work, engineering, and process tools. Lead and/or work as a team member to complete manufacturing investigations, process improvement and/or validation projects.  May serve as a technical reviewer/approver for process changes.  Qualifications Education Minimum Requirement: B.S. in Engineering Field Required Experience and Skills: Engineering educational background Minimum of 6-year post-Bachelor's degreeexperience in vaccines in support of Production, Process Engineering, Technical Services or related experience.  Product franchise tech services experience Experience with tech services support activities for introduction or launch of new product Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills Preferred Experience and Skills: Experience with validation documentation and execution Experience with Trackwise, MIDAS, SAP, MII, Delta V Experience with change control documentation and execution Experience with Clean-in-Place and Sterilize-in-Place systems Ability to read Piping and Instrumentation Diagrams Requisition ID: PRO018799
Salary Range: NA
Minimum Qualification
5 - 7 years

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