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.
