Sr. Specialist, Engineering Job

Durham, NC, US
September 26 2017
Organization Type
Sr. Specialist, Engineering-CHE005532


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.

We currently have an exciting opportunity for a Specialist to join Organon Teknika, a subsidiary of Merck, Technical Operations department within the Merck Manufacturing Division (MMD), supporting the BCG manufacturing facility in Durham, NC.

In this role, the candidate will serve on the Technical Operations IPT support team working with both Manufacturing Operations and Quality Operations. Furthermore, the candidate must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. 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 and strengthen process systems meeting both Quality and Supply needs is a must. 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. Off-shift or weekend coverage may be required occasionally, based on project-specific assignments.

Primary activities include but are not limited to the following:

- Provide on-floor support for all Production activities.
- Authors/Supports process changes, batch records and procedural updates
- Responsible for process system improvements
- Provides technical expertise and oversight on the production floor, understanding the full process requirements (safety, compliance, equipment, regulatory) in order to best understand and resolve production issues.
- Works with floor personnel to develop and implement standardized work.
- Supports process deviation investigations to provide meaningful immediate and preventive actions and reduce the deviation generation rate.
- Supports Sterility Assurance
- Supports Facility management
- Facilitates real-time formal problem solving techniques, such as root cause analysis and/or Lean Six Sigma tools



- Bachelor’s Degree or higher in Engineering or Science

- Minimum of 6 years’ experience in a GMP-related environment – OR – 4 years with a Master’s Degree or higher
- Experience with cGMPs and regulatory requirements as they apply to the vaccine/pharmaceutical 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
- Experience with technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols
- Willing and able to work both independently and within multi-functional teams in a fast-paced environment

- Skills in design of experiments (DOE)
- Advanced knowledge of Excel, Minitab, JMP, and/or S-plus
- Sterile Vaccine manufacturing experience
- Cell culture experience
- Six Sigma 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

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Visa sponsorship is not available for this position.

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Job: Chemical Engineering

Job Title:Sr. Spclst, Engineering

Primary Location: NA-US-NC-Durham

Employee Status: Regular

Travel: No

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: No

Company Trade Name:Merck