Specialist - MBR Author [HCGT #007205]

Benefits

Additional Information

Job Description The Manufacturing Execution System (MES) Specialist acts as a subject matter expert for authoring and updating electronic master batch records. The primary responsibility is to ensure that the deployment of the Werum/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 also be responsible for updating the Master batch records for MES integrations - DCS, SAP, LIMS etc. The specialist will be supporting MES trainings, collaboration, benefit realization, and standardization. The Specialist will follow the standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes. The MES Specialist is responsible for activities that include the following: Identifies and implements continuous process improvement opportunities. Sustain electronic Master Batch Records, bringing together knowledge of manufacturing processes, and standard Werum/Korber generic master batch record (GMBR) configuration. 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. Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing 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. Work directly with Manufacturing sites point of contacts to understand the requirements related to MBR/GMBRs and implements them following the SOPs and Life cycle procedures using electronic validation softwares like eVal (Kneat Validation Software). Education Minimum Requirement: - Bachelor's Degree and 5+ years of MES support experience or 7+ years of relevant MES experience Required Experience and Skills: - Direct experience with MES (PAS-X) with strong experience in MBR, GMBR design. - Proven track record of analytical skills, problem solving and attention to detail. - High personal integrity, credibility, and energy - Excellent communication and influencing skills while working with Global stakeholders (North America, Europe & Singapore). - Strong written and verbal communication skills Minimum five (5) years of experience in a production regulated industry. - Strong understanding of manufacturing principles/processes (preferably Biologics) and ability to translate manufacturing requirements into Automation/Digital Solution Preferred Experience and Skills: Knowledge of SAP Knowledge of L2 Systems (Historian, SCADA, DCS) integration with PAS-X MES Required Skills: Audit Management, Business Process Improvements, Data Management, Problem Management, Quality Management, Real-Time Programming, Software Development Life Cycle (SDLC) Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/19/2026 *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.