Sr. Spclst, Engineering - Projects

Merck & Co.-posted about 1 year ago
Full-time • Mid Level
Onsite • West Point, PA
1,001-5,000 employees
Chemical Manufacturing
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The Senior Specialist, Engineering (Projects) role within the ROTA E2E Strategic Projects Technical Operations team at our West Point, PA campus is focused on providing end-to-end technical support for commercial vaccine products. This position is integral to enhancing the performance and results of multiple vaccine manufacturing and packaging areas, ensuring compliance and efficiency in operations.

  • Lead and execute technical projects through all phases, including project planning, management, and execution.
  • Support, execute, and/or lead continuous improvement projects aimed at increasing compliance and efficiency.
  • Investigate Corrective/Preventive Actions (CAPAs) and initiatives to improve Right-First-Time performance.
  • Manage project timelines to ensure compliance and customer deadlines are met, escalating potential delays as needed.
  • Collaborate with various teams including Coaches, Operators/Mechanics, Quality, and external vendors to resolve complex issues.
  • Provide advanced technical support for complex problems related to processes and equipment.
  • Design, conduct, review, and approve experimental protocols as necessary.
  • Author, update, and review technical and manufacturing documents required for engineering studies and change controls.
  • Support regulatory inspection activities and provide on-the-floor support for operational issues.
  • Bachelor's degree in engineering or equivalent technical field.
  • Minimum five years of experience in a GMP functional area or support of a GMP functional area.
  • Strong communication, collaboration, and leadership skills.
  • Experience in Biologics, vaccine, or bulk sterile manufacturing facilities.
  • Demonstrated strong performance record and excellent project management skills.
  • Proficiency with pharmaceutical industry technical business processes such as change control and deviation management.
  • Experience in technology transfer and/or start-up projects.
  • Regulatory inspection presentation experience with external regulatory authority representatives.
  • Health insurance coverage
  • Dental insurance coverage
  • 401k retirement savings plan
  • Paid holidays
  • Flexible scheduling options
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