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 Deviation Management Specialist, Engineering will provide technical support for the 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.
- 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
- Lead medium complexity investigations with input from SMEs; proficient on low complexity investigations
- Lead small projects or provide technical support for more complicated projects
- Represent site on cross-functional teams as required
- Provide floor coverage in support of QN initiations and fact finding activities
- Initiate Quality Notifications as required
- Mentor new employees and manage summer interns as required
Education Minimum Requirement:
- Bachelor’s Degree in Engineering, Sciences or related field
- Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols.
- Ability to conduct multiple investigations within established deadlines
- 2 years’ experience in pharmaceutical, biotech or other regulated industry
- 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.
- Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment validation
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.
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Visa sponsorship is not available for this position.
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Job: Engineering Generic
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh
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