Senior Specialist Job - United States
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
As part of West Point Technical Operations, the LVV Projects Group is seeking a highly motivated individual to support Varicella and MMR vaccine end-to-end projects. The LVV Projects Group is a customer-focused organization designed to lead and provide support for strategic initiatives and site objectives.
The LVV Projects Group provides technical and project management leadership by implementing strategic initiatives across the LVV end-to-end network, thus enabling reliable supply and continued growth. The selected individual will collaborate with cross-functional teams that include Operations, Technical Services, Quality, Automation, Regulatory, Global Technical Operations, Global Vaccine and Biologic Commercialization, MRL, and Supply Chain Management to lead and/or facilitate execution of strategic WP site projects. The individual may be part of a team assigned to execute a large project or will be expected to work independently to manage a series of smaller projects within the LVV E2E portfolio.
- Develop and maintain subject matter expertise in technical elements of Varicella, MMR, filling and/or LYO manufacturing processes.
- Build and maintain relationships with LVV E2E IPT technical operations and operations leaders and stakeholders.
- Recognize and advocate for improvement opportunities; implement opportunities within a prioritized portfolio
- Manage projects (scope/resource/schedule development and ongoing maintenance, risk identification and mitigation, appropriate issue escalation and data-driven recommendations and decision) to assure they meet compliance and process requirements.
- Laboratory and/or full scale experiment design and execution or manufacturing data analysis as needed for technical issue resolution.
- Authors and updates technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstration, change control and validation.
- Works as a team member of cross-functional teams to implement strategic projects
- Participates in regulatory inspection activities, as necessary.
- B.S. Degree in Engineering or Sciences
- Six (6+) years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 4 years; PhD degree plus 2 years).
- Three (3+) years project leadership and/or management
- Highly developed written and verbal communication, leadership and teamwork skills.
- Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role.
- Experience and understanding of regulations, familiarity with regulatory environment and industry trends for bulk manufacturing and filling processes.
- Advanced degree (M.S., Ph.D.) in science or engineering (Mechanical, Materials or Packaging preferred)
- Change execution management
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
- Regulatory inspection presentation experience with external regulatory authority representatives.
- Six Sigma - Black or Green Belt certification
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Engineering Generic
Job Title:Sr. Spclst, Engineering
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 2
Hazardous Materials: The responsibilities of this position require the employee to enter core sterile manufacturing areas.
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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