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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Manufacturing Execution System (MES) Sr. Specialist / Business Consultant acts as an area(s) site MES key point of contact, for Operations areas utilizing electronic Master Batch Records. The MES Sr. Specialist's primary responsibility is to ensure that the deployment of the Werum PAS-X electronic Master Batch Records are successfully and compliantly designed, developed, deployed, and supported to maximize business benefits and are in line with site business process and technical standards. The MES Sr. Specialist will have regular direct interaction with site COMET Data Center of Excellence (CoE), Tech Ops, Operations, Quality, and IT plus collaborate with the above site MES CoE. The MES Sr. Specialist will also be accountable for SAP-MES data integration, along with driving MES training, collaboration, benefit realization, and standardization across the site. The Sr. Specialist is responsible for following standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes.
Under the management and supervision of the SCM MES COE, the MES Business Consultant is responsible for activities that include the following:
Qualifications: Education Minimum Requirement:
- Partner with local Tech Ops, Quality, and Operations resources to design, develop, revise, train, and sustain electronic Master Batch Records, bringing together knowledge of the vaccine manufacturing process, and standard Werum generic master batch record (GMBR) configuration.
- Manages and coordinates resources supporting the deployment and sustainment of MES at the West Point site.
- Manages batch record update schedule to meet business needs and minimize unscheduled updates.
- Constructs/oversees the content of electronic Master Batch Records (eMBRs), with knowledge of vaccine products, critical process parameters (CPPs), critical quality attributes (CQAs), and Limited Review concepts.
- Application of sound project management techniques to meet schedule, budget, benefit realization and other project objectives.
- Integrates all of the MES relevant SAP recipe data elements within the electronic Master Batch Records, ensuring successful interface handshakes between the SAP Process Order and their corresponding Electronic Bach Record.
- Executes the appropriate change control and electronic Master Batch Record life-cycle actions and processes to assure the MES system is in a state of control and compliance.
- Participates in the creation and execution of the site MES SOPs and Werum training strategy and sustainment for end users.
- Identifies, communicates and implements eMBR changes that will accelerate or expand the benefit realization.
- Identifies and implements continuous process improvement opportunities.
- Assists with troubleshooting and efficiently resolving manufacturing problems, providing level 2 MES support to ongoing Electronic Batch Record (EBR) operations
- Knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with project teams and their site Quality unit.
- Assists in external agency inspections as needed.
- Contractor management
Required Experience and Skills:
- Bachelor's Degree (or five (5) years MES authoring experience)
Preferred Experience and Skills:
- Manufacturing operations or direct support experience with technology or quality
- Knowledge of Merck systems (PAS-X and SAP)
- Experience with Project Management and/or Change Control
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. 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.
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