Job Description
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
The Manufacturing Execution System (MES) Specialist position is at the Maurice R. Hilleman Center for Vaccine Manufacturing which is located in northern Durham, North Carolina. This state of the art facility, started in 2004, is manufacturing our Company's lifesaving vaccines. Due to the importance of this facility in our Company's Vaccine Manufacturing Supply Chain, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people. The successful MES Specialist candidate will have the opportunity to work in a dynamic and growing facility, and influence and ensure that our Vaccine products are available to customers throughout the world.
Supporting the world market will occur through ensuring the MES meets ongoing and future manufacturing requirements, assures its configuration is aligned with regulatory requirements, maximizes business benefits, and aligns it with our Company's business process and technical standards. The MES Specialist is responsible for supporting MES implementations across the full systems lifecycle, from identifying the business and technical needs of users, determining appropriate implementation of the technology, executing implementation, and maintaining ongoing operations. The MES Specialist will have regular direct interaction with the MES users, ERP and Process Automation experts, and interface with our Company's MES Center of Excellence.
This specific role will be based at the Durham North Carolina manufacturing facility.
The MES Specialist is responsible for activities that include the following:

• Gain detailed knowledge of Werum's PAS-X MES application to enable production execution, including interfaces for ERP and DCS.
• Partner with site users and project teams to meet their needs through MES configuration. This includes active participation in the configuration of MES, then hands-on shop floor training and implementation which will require periodic shift and weekend support.
• Maintain MES as it relates to PAS-X system configuration, SDLC, validation development/execution, hardware, software environments, SOPs and business processes.
• Collaborate in a network with other MES Subject Matter Experts to ensure that best practices are shared and resolve MES related investigations. Where required, participate in MES user groups within our Company to continuously improve the application and associated use practices.
• Actively participate in the refinement of PAS-X end-user training requirements they relate to configuration standards and operational activities.
• Provide MES on-call support to address and investigate system issues.

Education Minimum Requirement:

• BS in Engineering, Computer Science, or other technical degree.

Required Experience and Skills:

• Minimum of 3 years of experience front line supervision, process development, and/or process automation/IT support within the Pharmaceutical/Biopharmaceutical manufacturing business.
• Proven skills with integrated Manufacturing Execution Systems.
• Proven change management skills implemented at a manufacturing site level are essential.
• Excellent understanding of cGMP, and Process Automation System Life Cycle methodologies.
• Excellent written and oral communication skills.
• Excellent facilitation, problem solving, and decision making skills.

Preferred Experience and Skills:

• Master Batch Record configuration experience using Werum's MES, PAS-X.
• SAP configuration experience for Production Execution.
• Distributed Control System, especially Emerson's DeltaV, coding experience for Process Automation.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are ...
We are known as Merck & Co., Inc., Rahway, 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 ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Residents of Colorado:
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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
25%
Flexible Work Arrangements:
Shift:
1st - Day
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R195461