Sr. Spclst

Job Description

The Manufacturing Execution System (MES) Senior Specialist acts as a subject matter expert for PAS-X MES focusing on electronic batch records design. 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 Senior Specialist will also be responsible for updating the Master batch records for MES integrations – DCS, SAP etc.  The Senior Specialist will be supporting MES implementations, product trainings, standards development, technical development of PAS-X specialist team in India. The Sr. Specialist is responsible for following standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes. The MES Sr. 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).

·       Manages the GMBR design needs for group of sites from a region – NA, EU etc. using demand and talent planning skills.

Education Minimum Requirement:

• Bachelor's Degree and 8+ years of MES (PAS-X) experience or 12+ years of relevant MES experience

Required Experience and Skills:

·       Direct experience with MES (PAS-X) with strong experience in MBR, GMBR design, Integrations (SAP and L2 Systems with PAS-X) .

·       Proven track record of analytical skills, problem solving and attention to detail.

·       Demand and Talent Planning experience while implementing MES projects, tasks.  

·       High personal integrity, credibility, and energy

·       Excellent communication and influencing skills.

·       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 (Aveva PI Historian, SCADA, DeltaV DCS) integration with PAS-X MES

Required Skills:

Accountability, Audit Management, Automated Manufacturing Systems, Automation, Automation Testing, Biopharmaceuticals, Business Management, Business Operations, Business Process Improvements, Change Controls, Communication, Continuous Process Improvement, Data Management, Detail-Oriented, Manufacturing Execution Systems (MES), Manufacturing Processes, Problem Management, Quality Management, Real-Time Programming, SAP HCM, Software Development Life Cycle (SDLC), Standards Development

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/15/2026

*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.

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