Manager 2, MES - SME

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.

• MES Implementation
  :
  Represent site‑specific needs during MES design, configuration, and deployment.
• Validation Leadership
  :
  Lead IQ, OQ, PQ, UAT, and traceability matrix execution.
• Documentation Ownership
  :
  Manage GxP documentation (URS, FS, DS, test cases, validation plans/reports).
• MES Product Expertise
  :
  Maintain deep knowledge of MES functionality and architecture.
• Front‑End Support
  :
  Act as the first point of contact for MES application issues and user support.
• Training & Adoption
  :
  Deliver training and ensure user readiness for MES usage.
• Data Management
  :
  Support data collection, migration, and master recipe creation.
• Audit Readiness
  :
  Ensure all documentation and systems are compliant and audit‑ready.

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Primary Sites:
Halol and Baska manufacturing sites

• Bachelors degree in Engineering – Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
• Preferable Masters degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related fields.
• Certifications:
  
  GAMP 5 for system validation in regulated environments, CSV for compliance with GxP, MES platform certifications (e.g., Werum PAS‑X, Siemens Opcenter, Rockwell), 21 CFR Part 11 compliance training for electronic records and signatures.

• Strong understanding of pharma shop floor operations and regulatory requirements.
• Prior hands‑on experience with MES platforms or similar systems in GxP‑regulated environments.
• Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems.
• Experience in resolving front‑end MES issues and supporting end‑users post‑deployment.
• Familiarity with audit processes and documentation expectations.

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.

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 decision‑making, and comfort working on the shop floor and in technical environments.

• Knowledge of data analytics tools.
• Edge cloud deployment experience with IoT and IIoT.
• L2 integration with MES.
• MES integration with SAP.
• Understanding of network and databases.

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!

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).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.