Merck Senior Engineer - Technical Operations in Durham, North Carolina

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.

We currently have an exciting opportunity for a Sr. 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, with focused responsibilities on deviation management 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 leadership, technical writing, 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:

  • Authors/leads investigations of deviation events

  • Creates meaningful immediate and preventive actions and reduce the deviation generation rate

  • Manages site deviation metrics / systems

  • Supports/leads production and quality 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.

  • Facilitates real-time formal problem solving techniques, such as root cause analysis and/or Lean Six Sigma tools.

Education Minimum Requirement:

  • 4 year degree in (bio)Chemical Engineering or similar degree.

Required Experience and Skills ** :

  • 6 years of experience in a GMP-related environment (or 0 years required advanced degree)

  • Working knowledge of cGMPs and of 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.

  • Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols

  • Experience with presenting to an internal / regulatory auditor.

  • Must be able to work both independently and within multi-functional teams in a fast-paced environment.

Other:

· Medical clearance to work at the Organon Teknika facility

Preferred Experience and Skills:

  • Skills in design of experiments (DOE)

  • Experience leading and/or facilitating a team for problem solving / investigative purposes.

  • 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 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 at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at http://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

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

Job Chemical Engineering

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

Title: Senior Engineer - Technical Operations

Primary Location: NA-US-NC-Durham-RTP

Requisition ID: CHE005941