MES & Digital - Senior Automation Engineer (Pharma)

Automation Design & Architecture:

• Develop product recipe strategies across the full application layer of ERP, MES and DCS Batch.
• Create ISA-88/ISA-95-aligned architecture diagrams, including Application and Data Flow diagrams.
• Ensure architecture supports scalability, cybersecurity, data integrity, and multi-product flexibility.

URS / FRS / Design Documentation:

• Work cross functionally to translate process requirements into robust digital system design documents.
• Lead the creation, review, and approval of URS, FRS, DS / DDS, Functional & Control Narratives.
• Create Recipe Design Documentation (ISA-88 compliant), Automation Standards & Engineering Guidelines.

Digital System Implementation:

• Develop, modify, and test MES (eBR, RbE, eLogbooks, Equipment Tracking, Weigh & Dispense), LIMS, Serialization and CMMS application functionality.
• Support integration of OEM skids such as bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment.

Commissioning, Validation & GMP Compliance:

• Ensure all changes meet data integrity requirements, change control processes, and validation lifecycle rules.
• Lead deviation investigations, CAPAs, and risk assessments related to Digital systems.