Sr. Specialist Engineering, CTU SME

West Point, PA, US
April 06 2018
Organization Type
Requisition ID: ENG003776

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, Engineering, will beresponsible for the oversight the controlled temperature mapping (CTU)practices in the West Point site as part of the Bio-Sterile Validation (BSV)Subject Matter Expert (SME) team.  Theprimary responsibility of the individual will be supporting Integrated ProductTeams (IPTs) involved in vaccine manufacturing.   Also, when required the Senior SpecialistSME will be required to train and coach junior engineer/specialist in areassuch as temperature mapping for freezer, cold vaults, warehouse and laboratorytemperature units.


Additional responsibilities include thefollowing:

  • Responsiblefor defending site and company validation policies/practices in front ofregulatory agencies during inspections and regulatory submissions.
  • Generateand approve validation assessment for changes to validated state of control forequipment and component
  • Supportsite troubleshooting activities during investigation and process improvementactivities.
  • TheSME is responsible to ensure the West Point site is in compliance with Merckglobal guidelines
  • Completegap assessments for Merck global guidance and perform remediation activities toensure site compliance.
  • Supportsite IPTs during investigations as a controlled temperature mapping subjectmatter expert.
  • Supportand oversee CTU revalidation metrics for site compliance
  • Providevalidation strategy support for implementation of new Units (e.g. site capitalprojects) by reviewing and approving validation related documents when requiredto ensure West Point compliance.
  • Interfacewith global validation group to ensure validation practices are aligned acrossMerck & Co., Inc. network.
  • Supportnew or existing product regulatory filing requirement and provide subjectmatter expertise review throughout the process.


Education Minimum Requirement:  

  • BS, Preferably in Engineering or Sciences 

Required Experience and Skills:

  • Minimumof 7 years relevant work experience, hands on experience on controlledtemperature units system validation in sterile products manufacturing and laboratory operations.
  • Strong knowledge on regulatory expectation for temperature-controlled systems (e.g. EU, FDA)  
  • Strongknowledge and hands on experience calculating and interpreting data fromvalidation studies
  • Demonstratestrong knowledge on different types of control temperature units andtemperature mapping concepts
  • Strongcommunication, collaboration skills and ability to drive accountability
  • Strongbackground solving analytical and/or complex problems

Preferred Experience and Skills:

  • Minimumof 5 years work experience on managing and executing controlled temperatureunits programs for manufacturing and/or laboratory operations.
  • Experienceinteracting with regulatory agencies

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


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 

Job: Engineering Generic
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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