Job Description

Job Summary
We are looking for a seasoned professional with 10-15 years in the Indian pharmaceutical industry , including 3+ years specializing in Manufacturing Execution Systems (MES) and L2 integration. This role demands expertise in optimizing MES platforms (e.g., Werum-PASX , Siemens Opcenter, Rockwell PharmaSuite) and integrating Level 2 systems (SCADA, PLCs, historians) to enhance manufacturing efficiency, compliance, and digital transformation. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5) while driving innovation in pharma manufacturing processes.
Experience with implementing greenfield MES and/or being part of core team from inception will be a big plus.
Key Responsibilities
MES Leadership:
- Lead MES implementation, upgrades, and harmonization across sites
- Optimize workflows (e.g., batch records, electronic logbooks) to align with cGMP.
- Collaborate with IT/OT teams to ensure seamless MES-ERP (e.g., SAP) integration
Cross-Functional Collaboration:

• Mentor teams on MES/L2 best practices and digital tools (IIoT, Industry 4.0)
• Work with QA teams during audits

• Work with QA, production, and supply chain to streamline processes

Innovation:

• Identify opportunities for advanced analytics, AI/ML, and paperless manufacturing.
• Stay updated on emerging technologies and regulatory trends.

Qualifications
Education: Bachelor's in Chemical/Pharma Engineering, Computer Science, or related field. Master's preferred.
Experience:
- 10+ years in pharma manufacturing/operations, with 3+ years in MES implementations; experience in doing L2 integrations and OT setup will be a big advantage.
- Hands-on experience with MES platforms (e.g., Werum PAS-X) ; preferred if also proficient on L2 systems (Ignition SCADA, OSIsoft PI etc. ).
- Strong grasp of ISA-95 standards, 21 CFR Part 11, and data integrity principles will be a plus
Skills:
- Project management (Agile/Waterfall) and leadership.
- Technical troubleshooting and scripting (SQL, Python).
- Excellent communication for stakeholder alignment.
- Certifications (Preferred): PMP, Six Sigma, GAMP5.
Preferred Skills

• Experience with ERP interfaces (SAP S4HANA) and L2 integration
• Experience on cloud-based MES and L4 integration a plus

Knowledge of data analytics tools (Power BI, Tableau) and IIoT platforms.