Halol, Gujarat, India · On-site
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…
Skills: MES Configuration, System Validation, GxP Compliance, 21 CFR Part 11, IQ OQ PQ UAT
Mumbai City, Maharashtra, India · On-site
Job Title: Manager / Sr. Manager – Inventory Management Business Unit: SCM Job Grade Location : Mumbai – Sun House At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you…
Skills: Inventory Management, Supply Chain Management, Material Planning, Inventory Optimization, Working Capital Management
United States · On-site
$115k–$170k/yr
The Account Manager – Cutaneous Oncology is a field-based sales role responsible for driving demand and market share growth for Odomzo® and Unloxcyt™ within an assigned territory. This individual will build and maintain …
Skills: Sales, Oncology, Dermatology, Strategic business planning, Relationship management
Delhi, India · On-site
Job Title: Clinical Research Associate Business Unit: Medical Affairs & Clinical Research Location: Delhi At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at …
Skills: Clinical Research, Site Feasibility, Budget Negotiation, GCP Principles, Site Monitoring
Mercer County, New Jersey, United States · Hybrid
$111k–$135k/yr
Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and pati…
Skills: Strategic planning, Event management, Project management, Budget management, Vendor management
Mumbai City, Maharashtra, India · On-site
Job Title: Manager / Sr. Manager – Inventory Management Business Unit: SCM Job Grade Location : Mumbai – Sun House At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you…
Skills: Inventory management, Supply chain management, Inventory strategy, Governance, SAP
Delhi, India · On-site
Job Title: Clinical Research Associate Business Unit: Medical Affairs & Clinical Research Location: Delhi At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at …
Skills: Clinical Research, Site Feasibility, Budget Negotiation, GCP Principles, Site Monitoring
Mumbai City, Maharashtra, India · On-site
Job Title: Sr.Manager - Procurement Business Unit: Procurement Job Grade Location : Acme Plaza At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step,…
Skills: Production planning, Contract manufacturing management, Cost reduction, Regulatory compliance, New product launches
Texas, United States · On-site
$185k–$225k/yr
Regional Business Director of Field Reimbursement (Gulf Coast) The Region Business Director of Field Reimbursement is a field based leadership role supporting the market access strategy for the Sun family of products acr…
Skills: Field leadership, Market access strategy, Reimbursement, Health policy, Patient access
Mumbai City, Maharashtra, India · On-site
Job Title: Manager /Sr Manager – Internal Audit Business Unit: Global Internal Audit Job Grade : Location : Mumbai Independently lead audits, including audit planning, audit execution, drafting the internal audit report,…
Skills: Internal Audit, Audit Planning, Audit Execution, Internal Controls, Risk Control Matrix
United States · On-site
$115k–$175k/yr
The Account Manager – Cutaneous Oncology is a field-based sales role responsible for driving demand and market share growth for Odomzo® and Unloxcyt™ within an assigned territory. This individual will build and maintain …
Skills: Sales, Oncology, Dermatology, Strategic business planning, Account management
Mumbai City, Maharashtra, India · On-site
Job Title: Manager / Sr. Manager – Inventory Management Business Unit: SCM Job Grade Location : Mumbai – Sun House At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you…
Skills: Inventory Management, Supply Chain Management, Inventory Strategy, Governance, SAP
Mercer County, New Jersey, United States · Hybrid
$233k–$284k/yr
Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and pati…
Skills: Pharmaceutical analytics, Forecasting, Data governance, Predictive analytics, Market research
United States · On-site
$111k–$140k/yr
Job Title: Account Manager – Cutaneous Oncology Location: Bakersfield, CA (Bakersfield/Fresno) Reports To: Regional Sales Manager Products: Levulan® Kerastick® + BLU-U® Blue Light Photodynamic Therapy Position Summary: T…
Skills: Sales, Dermatology, Account management, Buy-and-bill, Medical device sales
United States · On-site
$115k–$175k/yr
The Account Manager – Cutaneous Oncology is a field-based sales role responsible for driving demand and market share growth for Odomzo® and Unloxcyt™ within an assigned territory. This individual will build and maintain …
Skills: Sales, Oncology, Dermatology, Strategic business planning, Account management
Mercer County, New Jersey, United States · Remote OK
$180k–$225k/yr
POSITION TITLE: Regional Accounts Director, U.S. Government Business (USGB) POSITION SUMMARY The Regional Accounts Director will call on key personnel within any or all of the following entities; Veterans Affairs, Depart…
Skills: Market access strategy, Federal marketplace, Business planning, Sales, Account management
India · On-site
Walk-in interview For Sun Pharmaceutical Industries Limited, Job Location: Dadra & Nagar Haveli Date: 9th Aug 26 (Sunday) We are recruiting for our OSD manufacturing facility located at Dadra Time: 10 AM to 4 PM Intervie…
Skills: OSD Manufacturing, Granulation, Compression, Coating, Bottle Packing
Mumbai City, Maharashtra, India · On-site
Job Title: Group Product Manager - CNS Business Unit & Location India Business , Mumbai At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take c…
Skills: Strategic Planning, Operational Planning, Product Life Cycle Management, Market Intelligence, Budget Management
Baroda, Rajasthan, India · On-site
Areas Of Responsibility 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 …
Skills: Patent drafting, Patent prosecution, NCE portfolio management, Life cycle management, Competition tracking
Mumbai City, Maharashtra, India · On-site
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…
Skills: Kinaxis Maestro, Kinaxis Rapid Response, Supply chain management, Demand planning, Supply planning
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Responsible for the implementation and technical ownership of Manufacturing Execution Systems (MES) and L2 systems at the Halol and Baska sites. This includes leading validation activities, managing GxP documentation, and providing end-user support and training.
Requires a Bachelor's degree in Engineering or Pharmaceutical Sciences with 6-8 years of experience in the pharmaceutical industry. Expertise in MES platforms, GAMP 5, and CSV is essential for ensuring regulatory compliance.
|
|
|
|
|
|||
|
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
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 |
||||||
|
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). |
Reaching People. Touching Lives.
Sun Pharma is the world's fourth-largest speciality generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma's global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe, and a multicultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 3,000 scientists and R&D investments of over 6-8% of annual revenues. At Sun, our people are our greatest asset. Ours has never been a story of individual brilliance but of cultivating a culture of realising collective potential. In our journey, everyone is enabled to take charge in an environment that offers limitless growth opportunities. We are with you every step of the way, so you can shine for years to come. With the launch of our Employee Value Proposition (EVP), we define our promise to ‘Create Your Own Sunshine'—driven by the three pillars of Better Every Day, Take Charge, and Thrive Together. These pillars drive progress at Sun so that people can achieve what they would have thought impossible. Learn more about our EVP here: https://sunpharma.com/careers/
Offices: Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN
Reaching People. Touching Lives.
Sun Pharma is the world's fourth-largest speciality generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma's global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe, and a multicultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 3,000 scientists and R&D investments of over 6-8% of annual revenues. At Sun, our people are our greatest asset. Ours has never been a story of individual brilliance but of cultivating a culture of realising collective potential. In our journey, everyone is enabled to take charge in an environment that offers limitless growth opportunities. We are with you every step of the way, so you can shine for years to come. With the launch of our Employee Value Proposition (EVP), we define our promise to ‘Create Your Own Sunshine'—driven by the three pillars of Better Every Day, Take Charge, and Thrive Together. These pillars drive progress at Sun so that people can achieve what they would have thought impossible. Learn more about our EVP here: https://sunpharma.com/careers/
Offices: Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN
