Senior Specialist, Project Engineer - Bulk Manufacturing

Date: Feb 15, 2019

Location: Elkton, VA, US

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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 degree experience 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

#LI-HW2

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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 

          OFCCP EEO Supplement

 
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.


Job: Process Engineering
Other Locations: West Point, PA, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials:
Company Trade Name: Merck


Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia

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