Sun Pharmaceuticals Industries Inc. is seeking a Senior Executive to join our core team implementing a Manufacturing Execution System (MES) at one of our pharmaceutical manufacturing plants. This role is pivotal in ensuring our digital transformation aligns with Good Manufacturing Practices, meets all regulatory requirements, and drives operational excellence.
What You'll Do
- Act as the manufacturing subject matter expert for MES implementation in a GMP-regulated environment.
- Collaborate with cross-functional teams to define and document detailed MES requirements.
- Participate in process mapping, recipe modeling, and electronic batch record (EBR) design.
- Support the configuration and validation of MES modules including EBR, Weighing & Dispensing, and Equipment Management.
- Ensure system alignment with regulatory standards like 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Assist in data migration, system testing (IQ/OQ/PQ), and go-live readiness activities.
- Train end-users and provide post-implementation support and troubleshooting.
- Identify process improvement opportunities and contribute to continuous improvement initiatives.
- Coordinate with IT and automation teams to ensure seamless integration between MES, ERP, and shop floor systems.
- Participate in change control processes and ensure proper documentation of system changes.
- Monitor system performance after implementation and support optimization efforts.
- Contribute to the development of SOPs, work instructions, and training materials related to MES.
- Support audit readiness and respond to internal and external audit queries.
- Facilitate workshops and feedback sessions with production teams to ensure MES usability.
- Track and report project milestones, risks, and issues to the MES Project Manager.
What We're Looking For
- A Bachelor’s degree in Pharmacy, Chemical Engineering, Biotechnology, or a related field.
- 7+ years of experience in pharmaceutical manufacturing operations.
- A minimum of 3 years of direct experience with Manufacturing Execution Systems (MES).
- Strong understanding of GMP, GDP, and regulatory compliance in the pharmaceutical industry.
- Familiarity with batch manufacturing processes, cleanroom operations, and documentation practices.
Nice to Have
- Prior involvement in a full-scale MES implementation or other digital manufacturing projects.
Technical Stack
- Manufacturing Execution System (MES)
- Electronic Batch Records (EBR)
- ERP systems
Team & Environment
You will be a member of the MES implementation core team, collaborating closely with cross-functional partners in QA, IT, Engineering, Validation, and Production. You will report directly to the MES Project Manager.
Work Mode
This is an onsite position.
