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 Senior Specialist Business Consulting, serves as the subject matter expert for the Manufacturing Execution System (MES) for new product feasibility team located at the Durham, NC facility, while actively supporting an inclusive team culture.
Responsibilities may include but are not limited to:
- Providing technical leadership for the assigned area and system(s) to ensure a compliant and reliable supply of product and on time project execution with production shop floor support as needed
- Application of sound project management techniques to meet schedule, budget, benefit realization and other project objectives.
- Providing direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expert
- Providing technical guidance/support including authoring or review and approval of automation incidents, Quality Notifications (QNs), system commissioning and qualification, change control, and other key automation related processes
- Assisting in the development and review and approval of department SOPs and other site GMP SOPs related to automation and digital activities and adheres to established quality standards
- Supporting problem solving practices to identify and resolve technical and operational problems; able to collaborate with peers to resolve problems that cross into inter-related units
- Other duties requested by Management.
- Reports to the Associate Director Business Consulting
- Frequent interaction with employees from other departments
- Interacts with representatives from regulatory agencies and external suppliers
Education Minimum Requirement:
- Bachelor’s Degree and three (3) years of MES support experience or (5) years of MES support experience
Required Experience and Skills:
- Minimum five (5) years of experience in a production regulated industry
- Minimum of five (5) years of experience in a GMP manufacturing automation related role and direct experience with SDLC and change controls
- Direct experience with MES
- Demonstrated ability to build relationships with team, peers and area leads
- Demonstrated leadership in achieving shared objectives in a matrix organization
- Strong understanding of manufacturing principles/ processes and ability to translate manufacturing requirements into Automation/digital solution
- Proven track record of analytical skills, problem solving and attention to detail
- Able to demonstrate the Merck Leadership Principles and Enterprise Leadership
- High personal integrity, credibility, and energy
- Excellent communication and influencing skills
- Strong written and verbal communication skills in English
Preferred Experience and Skills:
- Direct experience with all levels of the S95 model from ERP to shop floor instrumentation and working knowledge of S88
- Data Integrity Acumen
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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