Specialist, Manufacturing Automation MES

Job Description

The Manufacturing Execution System (MES) Specialist acts as a subject matter expert and an area(s) site MES key point of contact, for Operations areas utilizing electronic Master Batch Records. The MES Specialist's primary responsibility is to ensure that the deployment of the Korber 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 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 Product Team. The MES Specialist will also be accountable for SAP-MES data integration, along with driving MES training, collaboration, benefit realization, and standardization across the site. The 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 MES Lead, the MES Specialist is responsible for activities that include the following:

• Assure MES and electronic batch records meet ongoing and future manufacturing requirements and is configured to align with regulatory requirements.
• Ensure MES and electronic batch records align with our Company business processes and technical standards.
• Responsible for supporting MES and electronic batch records implementations across full systems lifecycle.
• Identifying business and technical needs of users.
• Determining appropriate implementation of MES technology, executing implementation and maintaining ongoing operations.
• Uses existing procedures to solve routine or standard problems.
• Performs MES training of end users, such as Operations, Technology, Quality, as needed.
• Participate in MES 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.
• Assist inspections as needed.

FUNCTIONAL EXPERTISE:

• Detailed knowledge of Korber PAS-X MES application (v3.1.8) to enable production execution, including interfaces for ERP and DCS.
• Partner with site users and project teams to meet their needs through MES and electronic batch record configuration. This includes active participation in the configuration of MES and batch records, then hands-on shop floor training and implementation which may require periodic shift and weekend support.
• Maintain MES as it relates to PAS-X system configuration, SLC, 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.
• Collaborate on occasion directly with MES Center of Excellence (CoE).

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

EDUCATION:

• High School Diploma required.

REQUIRED QUALIFICATIONS:

• 1 year of experience in an operations, quality, or technical role within the pharmaceutical and or life science industry.
• Experience in technical writing or requirements, protocols, and test plans.
• Excellent written and oral communication skills.
• Excellent facilitation, problem solving and decision-making skills.

Preferred:

• Knowledge of integrated Manufacturing Execution Systems.
• Understanding of cGMP, and Process Automation System Life Cycle methodologies.
• Bachelor's Degree in Engineering, Computer Science or other technical degree preferred.

PHYSICAL REQUIREMENTS:

• Ability to gown aseptically.​

WORKING RELATIONSHIPS:

• Reports to Associate Director, MBR Factory
• Interacts with employees within own department.
• Frequent interaction with employees from other departments.
• Frequent interaction with ERP and Process Automation experts.
• Interacts with representatives from our Company's MES Center of Excellence.

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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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/26/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R298255