Manager 2, MES - SME

Sun Pharmaceutical Industries Ltd; United States; Presencial; USD 90 000 - 150 000; Tempo integral

Resumo da oferta

Sun Pharma is seeking a Site SME – MES Project with 6–8 years in pharma and hands-on MES/L2 experience. The role ensures site MES alignment with global standards, leads validation, and acts as the primary MES expert for Halol and Baska sites.

The candidate will manage documentation, provide end-user support, and drive training and adoption while ensuring compliance with FDA 21 CFR Part 11, EU GMP, and GAMP5.

Qualificações

• Bachelor’s degree in Engineering or IT, or related field.
• Master’s degree preferred in Industrial Automation or Pharma tech.
• GAMP 5 and CSV experience for validation in regulated environments.
• Experience with MES platforms (Werum PAS-X) is a strong plus.
• Strong pharma manufacturing and GxP compliance background.

Responsabilidades

• Represent site needs during MES design, config, and deployment.
• Lead IQ/OQ/PQ/UAT validation and traceability activities.
• Own GxP documentation: URS/FS/DS and test plans.
• Maintain MES product expertise and support front-end issues.
• Deliver training and ensure user readiness for MES usage.
• Support data migration and master recipe creation.
• Ensure audit readiness and regulatory compliance.

Conhecimentos

MES configuration

Validation

GxP compliance

Front-end support

Data migration

Communication

Formação académica

Bachelor's degree in Engineering/IT

Master's degree preferred

Ferramentas

Werum PAS-X

Siemens Opcenter

Rockwell

Descrição da oferta de emprego

Job Title:

Manager, MES – SME

Job Grade (refer to JE):

G11A

Function:

Global IT

Sub-function:

Manufacturing IT

Location:

Baska

Job Summary

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

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

Areas Of Responsibility:

• 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
• Behavioural: 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

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).