Merck Specialist, Engineering 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 an Engineering Specialist to join Organon Teknika, a subsidiary of Merck, Technical Support 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. 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.
The candidate may lead and/or support critical project initiatives at the site, support the ongoing sterility assurance program, and maybe involved in 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:
Supports/leads production and quality projects and process system improvements
Support or lead investigations of deviation events
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:
- B.S. degree in Engineering (such as Chemical, Mechanical, Bio-Engineering, Bio-Medical Engineering, industrial Engineering, etc.) or Science Fields (such as Chemistry, Biology, Microbiology, etc.)
Required Experience and Skills:
Minimum of 2 years of experience in a GMP-related environment.
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.
Experience in project management
Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.
Must be able to work both independently and within multi-functional teams in a fast-paced environment.
Preferred Experience and Skills:
Between 2-4 years of experience in a GMP-related environment.
Experience with presenting to an internal / regulatory auditor.
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 manufacturing 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.
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Visa sponsorship is not available for this position.
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Job Chemical Engineering
Title: Specialist, Engineering
Primary Location: NA-US-NC-Durham-RTP
Requisition ID: CHE006317