Job Description
The Manufacturing Execution System (MES) Sr. 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 Sr. Specialist's primary responsibility is to ensure that the deployment of the Werum/Koerber 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 Product Team. 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 MES Lead, the Senior Specialist is responsible for activities that include the following: Partner with local Tech Ops, Quality, and Operations resources as well as outsourced contracted services to design, develop, revise, train, and sustain-electronic Master Batch Records, bringing together knowledge of manufacturing processes, and standard Koerber generic master batch record (GMBR) configuration.
Manages and coordinates resources supporting the deployment and sustainment of MES. -
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 Koerber training strategy and sustainment for end users.
Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing MES support to ongoing Electronic Batch Record (EBR) operations.
Identifies and implements continuous process improvement opportunities.
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.
Education Minimum Requirement: Bachelor's Degree
-Required Experience and Skills: Minimum five (5) years of MES support experience within a production regulated industry.- -
Strong understanding of manufacturing principles/processes and ability to translate manufacturing requirements into Automation/Digital Solution
Proven track record of analytical skills, problem solving and attention to detail.
High personal integrity, credibility, and energy.
Excellent communication and influencing skills.
Strong written and verbal communication skills -
Experience with Project Management and/or Change Control
Knowledge of SAP
#eligibleforerp 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". 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:
No relocation VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Hybrid Shift:
1st - Day Valid Driving License:
No Hazardous Material(s):
N/A Requisition ID: R290364
