Job Description

Specialist, Manufacturing Execution System is responsible for supporting Manufacturing Execution System 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 that directly support the Maurice R. Hilleman Vaccine Manufacturing Facilities.

Duties:

• Assure Manufacturing Execution System meets ongoing and future manufacturing requirements and is configured to align with regulatory requirements.

• Ensure Manufacturing Execution System aligns with our Company's business processes and technical standards.

• Responsible for supporting Manufacturing Execution System implementations across full systems lifecycle.

• Identifying business and technical needs of users.

• Determining appropriate implementation of Manufacturing Execution System technology, executing implementation and maintaining ongoing operations.

• Uses existing procedures to solve routine or standard problems.

• Receives instruction, guidance and direction from others.

• Performs Manufacturing Execution System training of end users, such as Operations, Technology, Quality, as needed.

• Participate in Manufacturing Execution System on-call support 24x7 on a rotational basis.

• Builds own team effectiveness skills and promotes team effectiveness through own actions by demonstrating respect and appreciation for diverse perspectives.

Business Expertise:

• Applies general knowledge of company business developed through education or past experience.

• Understands and applies regulatory / compliance requirements relative to their role.

Functional Expertise:

• Gain detailed knowledge of Werum's PAS-X Manufacturing Execution System application (v3.1.8) to enable production execution, including interfaces for Enterprise Resource Program and DCS.

• Partner with site users and project teams to meet their needs through Manufacturing Execution System configuration. This includes active participation in the configuration of Manufacturing Execution System, then hands-on shop floor training and implementation which will require periodic shift and weekend support.

• Maintain Manufacturing Execution System as it relates to PAS-X system configuration, Sterile Liquid Commercialization , validation development/execution, hardware, software environments, Standard Operating Procedures and business processes.

• Collaborate in a network with other Manufacturing Execution System Subject Matter Experts to ensure that best practices are shared and resolve Manufacturing Execution System related investigations. Where required, participate in Manufacturing Execution System 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.

Problem Solving:

• Uses existing procedures to solve routine or standard problems.

• Applies limited judgment and discretion.

Internal Client/External Customer Focus:

• Responds to standard requests from clients and/or customers.

Impact:

• Errors on the job may cause production delays and impact the work of others in own work group

• Influence and Decision Making

• Communicates information, asks questions and checks for understanding.

• Has limited decision-making authority; works within technical guidelines and direction to achieve objectives and meet deadlines.

Project Management:

• Accountable for technical contribution to project team or sub-team.

Resource Management:

• Builds awareness of costs related to own work.

Education Requirement:

• Bachelor’s Degree in Engineering, Computer Science or other technical degree.

Essential Qualifications:

• Excellent written and oral communication skills.

• Excellent facilitation, problem solving and decision making skills.

Preferred:

• Knowledge of integrated Manufacturing Execution Systems.

• Understanding of Current Good Manufacturing Practices and Process Automation System Life Cycle methodologies.

• Knowledge of Werum PAS-X Manufacturing Execution System system version 3.1.8

Physical Requirement:

• Ability to gown aseptically.

Working Relationships:

• Reports to Associate Director, Business Consulting

• Interacts with employees within own department.

• Frequent interaction with employees from other departments.

• Frequent interaction with Enterprise Resource Program and Process Automation experts.

• Interacts with representatives from our Company's Manufacturing Execution System Center of Excellence.

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted 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., 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 our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

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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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.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R109734