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Job Summary
We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems.
The Site SME MES Project
is a key functional and technical expert responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at the Halol & Baska pharmaceutical manufacturing sites. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.
The SME is also accountable for leading site-level validation activities
and technical owner responsibility
, and managing all GxP documentation related to the MES & L2 system. The Site SME is the go-to authority for end-to-end MES product knowledge. This includes a deep understanding of system functionality, configuration, and compliance requirements.
The SME also serves as the first point of contact for any MES front-end application issues, supporting users in troubleshooting, training, and ongoing system usage post-go-live. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5)
Previous experience with Werum (Korber Pharma) for pharma industry is a big plus
Responsibilities:
MES Implementation:
Representing site-specific needs during MES design, configuration, and deployment.
Validation Leadership:
Leading IQ, OQ, PQ, UAT, and traceability matrix execution.
Documentation Ownership:
Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports).
MES Product Expertise:
Maintaining deep knowledge of MES functionality and architecture.
Front-End Support:
Acting as the first point of contact for MES application issues and user support.
Training & Adoption:
Delivering training and ensuring user readiness for MES usage.
Data Management:
Supporting data collection, migration, and master recipe creation.
Audit Readiness:
Ensuring all documentation and systems are compliant and audit-ready.
Travel Estimate
Less
Job Scope
Internal Interactions (within the organization)
Global MES Program Team:
Collaborating to align site processes with global standards and system templates.
Quality Assurance (QA) & QA IT:
Ensuring validation and compliance with GxP and CSV standards.
Business Users:
Engaging with production, quality, and operations teams for requirements gathering and support.
Engineering & IT Teams:
Coordinating technical aspects of MES deployment and integration.
Site Leadership
: Providing updates on MES implementation, validation status, and issue resolution.
End Users:
Supporting MES usage, troubleshooting front-end issues, and providing training.
External Interactions (outside the organization)
MES Vendors & Consultants:
Participating in workshops, configuration sessions, and demos; resolving technical issues.
Auditors & Regulatory Bodies:
Supporting audits by ensuring system and documentation compliance.
Third-Party Validation Experts:
Collaborating on validation strategy and execution if outsourced.
External Support Teams:
Engaging with vendor support for MES application troubleshooting and escalations.
Geographical Scope
Primary Sites: Halol and Baska manufacturing sites
Financial Accountability (cost/revenue with exclusive authority)
No direct financial authority
Job Requirements
Educational Qualification
Bachelor s degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
Preferred:
Master s degree (e. g. , MBA, M. Tech, M. Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields
Specific Certification
GAMP 5 for system validation in regulated environments.
CSV (Computer System Validation) for compliance with GxP.
MES Platform Certifications e. g. , Werum PAS-X, Siemens Opcenter, or Rockwell
21 CFR Part 11 Compliance Training for electronic records and signatures.
Experience
Pharmaceutical Manufacturing:
Strong understanding of pharma shop floor operations and regulatory requirements.
MES or Digital Systems:
Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments.
Validation Expertise:
Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems.
Application Support:
Experience in resolving front-end MES issues and supporting end-users post-deployment.
Audit Experience:
Familiarity with audit processes and documentation expectations
Skill (Functional & Behavioural):
Functional:
MES system configuration, deployment, and validation, Front-end application troubleshooting and user support, GxP and 21 CFR Part 11 compliance, Validation protocol development and execution (IQ, OQ, PQ, UAT), Documentation management (URS, FS, DS, traceability matrices), Data migration and master recipe creation
Behavioral:
Strong communication and interpersonal skills, Proactive problem-solving and risk management, High attention to detail and compliance mindset, Ability to work under pressure and manage multiple priorities, Detail-oriented with a focus on compliance and quality, Proactive problem-solving and decision-making, Comfortable working on the shop floor and in technical environments
Additional Skills: (Good to have)
Knowledge of data analytics tools
Edge Cloud deployment experience with (IoT and and IIoT)
L2 integration with MES
MES integration with SAP
Understanding of network and databases
