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 Associate Director Business Consulting, is responsible for management of the Manufacturing Execution System (MES) for the 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:
- Directing the technical activities of a professional staff to achieve facility business objectives with on the production shop floor support as needed
- Providing technical leadership for the assigned area and systems to ensure a compliant and reliable supply of product and on time project execution
- Providing direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expert
- Leading individual and team development through approved HR guidance and practices, while maintaining staffing at the agreed upon level any by actively engaging in efforts to recruit talent that supports a diverse and inclusive culture
- Providing guidance on system activities to the Integrated Process Team (IPT) leadership team with overall accountability for team and system performance within area of responsibility
- Providing guidance and ensuring that the team follow established standards, principles and governance;
- Providing technical guidance/support for key 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
- 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
- Adapting and implementing area plans and priorities based on IPT scorecard to address local business challenges
- Other duties requested by Management.
- Reports to the Director Manufacturing Automation
- Manages and interacts with employees within own department
- Frequent interaction with employees from other departments
- Interacts with representatives from regulatory agencies and external suppliers
Education Minimum Requirement:
- Bachelor’s Degree or higher in Engineering or Computer Science
Required Experience and Skills:
- Minimum eight (8) years of experience in a production regulated industry (part or all of the eight years providing manufacturing automation services) – OR – Master’s or MBA degree with six (6) years’ experience – OR – PhD with three (3) years’ experience
- 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 at least two of the three platforms 1) Process Automation (DeltaV/PLCs), 2) MES, and 3) PI (or equivalent)
- 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:
- Two or more years of direct people management experience
- Direct experience with all levels of the S95 model from ERP to shop floor instrumentation and working knowledge of S88
- Lean Six Sigma Experience
- 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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