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30 MSD Pharmaceuticals Jobs

Specialist, Manufacturing Automation

3-7 years

Pune

1 vacancy

Specialist, Manufacturing Automation

MSD Pharmaceuticals

posted 12hr ago

Job Role Insights

Flexible timing

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
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
02/6/2025
*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.

Employment Type: Full Time, Permanent

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What people at MSD Pharmaceuticals are saying

Specialist salary at MSD Pharmaceuticals

reported by 3 employees with 4-15 years exp.
₹18 L/yr - ₹33 L/yr
151% more than the average Specialist Salary in India
View more details

What MSD Pharmaceuticals employees are saying about work life

based on 257 employees
84%
37%
46%
100%
Flexible timing
Alternate Saturday off
Within city
Day Shift
View more insights

MSD Pharmaceuticals Benefits

Health Insurance
Job Training
Soft Skill Training
Education Assistance
Work From Home
Cafeteria +6 more
View more benefits

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