Senior Specialist Job

Employer
Merck
Location
West Point, PA, US
Posted
October 12 2017
Organization Type
Pharma
Requisition ID: ENG003431

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 125-year legacy. 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.

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.

Primary responsibilities include but are not limited to:
  • 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.
Qualifications

Education:
  • Bachelor’s Degree or higher in Engineering or Sciences
Required:
  • Minimum of six (6) years post-Bachelor’s Degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations – OR – Master’s Degree plus 4 years – OR – PhD Degree plus 2 years
  • Minimum of three (3) years’ project leadership and/or management experience
  • 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.
Preferred:
  • Master’s or PhD Degree in science or engineering (Mechanical, Materials or Packaging)
  • 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
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.



                     

If you need an
accommodation for the application process please email us at staffingaadar@merck.com.



 

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Visa sponsorship is not available for this position.

 

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Job: Engineering Generic
Other Locations:
Employee Status: Regular
Travel: No
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Company Trade Name: Merck