Senior Specialist, Engineering - West Point Technical Operations job in West Point
|Employer:|| Merck & Co.|
|Category:||Research and Development|
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.
The Senior Specialist, West Point Technical Operatoins is responsible for providing technical support to one of the vaccine manufacturing areas within Technical Operations. 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, executes, and/or leads continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
• Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Provides advanced technical support to manufacturing for complex problems and issues including process/equipment.
• Designs, conducts, and/or reviews and approves experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, change control.
• Supports regulatory inspection activities for the facility
• Provides on-the-floor support of complex operational and technical (process/equipment) issues.
• Performs and/or reviews and approves 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.
• Performs and/or reviews and approves customer complaint investigations aimed to prevent complaint re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.
• Completes and/or leads 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.
• Supports team safety, environmental, and compliance objectives.
• Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
• Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.
Education Minimum Requirement:
• B.S. Degree in Engineering or other equivalent technical field
Required Experience and Skills**:
• Minimum four (4) years' post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
• 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.
Preferred Experience and Skills:
• Change Control author/reviewer
• Deviation Management investigator/reviewer
• Customer Complaint investigator/reviewer
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities
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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Visa sponsorship is not available for this position.
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