Deviation Management Investigator:
Merck USA

Merck USA
Durham North Carolina
Requisition ID: ENG003742

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 Merck's Vaccine Technology & Engineering organization, the Site Deviation Management group is seeking a highly motivated individual to partner with Manufacturing Operations, Quality Operations, Automation and Bio-Sterile Validation. The Deviation Management Engineer will provide technical support for the state-of-the-art formulation and fill manufacturing facility in Durham, NC. The position requires strong technical writing skills and problem solving skills for conducting scientific investigations and data analysis to determine root cause, product impact, and develop corrective actions for unexpected results. The ability to design experiments to support investigations and lead investigations across a cross-functional area is expected as is the need to communicate results in a clear fashion. Enthusiasm for continuously learning is a requirement. The individual must embrace and be committed to establishing an empowered team culture, with the goal of each employee reaching their fullest potential and having accountability, authority and responsibility to one another, our community and our patients.

Primary Activities:
  • Lead troubleshooting and effectively resolve manufacturing atypical events. Develops and implements corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence. 
  • Off-shift and weekend coverage may be required depending on investigation needs. 
  • Interact directly with regulatory agencies from countries around the world.

  • Bachelor’s Degree or higher in Engineering or related discipline
  • Minimum of 1 year of experience in technical writing, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols
  • Experience with formal problem solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools
  • cGMP experience in a sterile, vaccine, bulk or finished pharmaceutical environment
  • Experience in a highly regulated industry

Your role at Merckis integral to helping the world meet new breakthroughs that affect generationsto come, and we’re counting on your skills and inventiveness to help makemeaningful contributions to global medical advancement. At Merck, we’reinventing for life.


If you need anaccommodation for the application process please email us at [email protected].


Search Firm Representatives Please ReadCarefully: 

Merckis not accepting unsolicited assistance from search firms for this employmentopportunity.  Please, no phone calls oremails.  All resumes submitted by searchfirms to any employee at Merck via email, the Internet or in any form and/ormethod without a valid written search agreement in place for this position willbe deemed the sole property of Merck.  Nofee will be paid in the event the candidate is hired by Merck as a result ofthe referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal EmploymentOpportunity, visit:

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