at Merck in Dover, Delaware, United States
The Senior Specialist, Business / Technical Analysis is responsible for working both independently and as a part of a team to implement Information Technology (IT) initiatives that will enable our company to deploy consistent global business processes, common global information, and IT supporting projects / application / technology suite. The individual will have expertise within IT requirements, supply chain, Manufacturing Requirements Planning and Enterprise Resource Planning (MRP/ERP) systems, and general business management.
The individual will work across all phases of projects and report progress to goals, manage any budget/profit plan activities, identify key risks and mitigation strategies, provide direct support for other process teams in the region as applicable, and complete other duties as needed or assigned.
This position requires knowledge and experience in own discipline while still acquiring higher-level knowledge and skills. The position will build knowledge of the company, processes, clients/customers and will solve a range of problems while providing possible solutions. This position may often work autonomously with a moderate level of guidance and direction. In group work, applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.
This Senior Specialist, Business / Technical Analysis position is responsible for providing client services support for new manufacturing information systems to the site including Manufacturing Execution System (MES), Electronic Batch Record (EBR), OSISoft PI historian, Rt Reports and supporting interfaces. This role will partner with site cross-functional teams and global support functions to ensure successful system functionality and operations.
This position will initially support a new pod vaccine manufacturing facility at the Wilson, NC Site. This position will be an individual contributor reporting to Director of Automation & Information Technology and will be a supporting member of the Vaccines integrated process team (IPT).
Primary activities include, but are not limited to:
The Senior Specialist, Business/Technical Analysis will be responsible for providing technical support and leadership to plant project teams, data management, interfaces to other systems, performance, growth analysis, contractor supervision, standards administration, documentation, continuity planning and design skills. The Senior Specialist is responsible for supporting the following as the discipline requires:
+ Understands and supports GMP, safety and environmental regulations and policies. Provides guidance to the IT team for appropriate procedures to ensure compliance with those policies. Periodically reviews technical documents and Guidelines and Standard Operating Procedures(GDLs/SOPs) to ensure compliance with our company’s guidelines and policies.
+ Understands and supports our company’s cybersecurity and data integrity policies and guidelines. Provides guidance to the IT team for appropriate procedures to ensure compliance with those policies. Reviews technical documents to ensure compliance with our company’s guidelines and policies.
+ Provides direct support of validation activities and other associated Quality functions required. Develops and maintains technical documentation as necessary. Participates in audit and training programs in area of responsibility.
+ Participates in agency inspections, internal GMP & systems audits and training programs in the area of responsibility
+ Evaluates automated and information technology systems developing strategies to optimize and ensure quality and stability through future expansion, replacement or upgrade.
+ Provides client services support as the IT lead on production teams providing technical assistance in fulfilling the IT requirements for the team.
+ Uses technical and business knowledge to assure the efficient operation of a variety of IT and Shopfloor systems. Oversees investigations of IT anomalies. Engages with business and IT support organizations to drive quick resolution to IT incidents, to investigate root cause and to prevent recurrence.
+ Supports the IT portfolio process by ensuring IT requirements are appropriately addressed during creation of business cases for new demand.
+ Works with IT support organizations Global Technology Operations (GTO), Application Maintenance & Services (AMS), IT Risk Management and Security (ITRMS, etc…) to communicate and minimize the impact of IT changes on manufacturing activities. Manages the relationship between support organizations and the business to ensure a positive, productive experience.
+ Manages IT projects in compliance with current Good Manufacturing Procedures (cGMPs). Serves as IT representative on major site projects. Oversees execution of user acceptance testing as required. Manages Go-live cutover activities and post go-live stabilization and support activities.
+ Provides leadership and acts as a catalyst to deploy IT technologies and programs as required. Coordinates change leadership interventions and activities.
+ Coordinates/Leads Kaizen events to aid in problem solving and/or continuous improvement opportunities.
+ Collaborates with colleagues at other sites of our company to discuss common issues and share best practices.
+ B.S., B.A., or M.S. in Information Technology/equivalent discipline.
+ Minimum of eight years’ experience in support of business / Information Technology in a corporate environment.
+ Demonstrated knowledge of enterprise wide projects and initiatives.
+ Demonstrated ability to lead key projects across multiple site disciplines and successfully manage multiple, concurrent projects.
+ Demonstrated ability to effectively lead others in a cross-functional organization.
+ Experience in computer validation and systems lifecycle development methodology.
+ Experience authoring and reviewing standard operating procedures, on-the-job-training, and other controlled documents.
+ Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment.
+ Demonstrated project management skills,
Preferred Experience and Skills:
+ Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies.
+ Experience with Manufacturing Execution Systems – preferably Werum PAS/X.
+ Experience with data historian systems – preferably OSISoft PI historian.
+ Working knowledge of the regulatory requirements for pharmaceutical applications.
+ Strong Data Integrity acumen.
+ PMP Certification.
Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to