We are looking to hire talents who lead the software architecture, configuration, and computerized system validation (CSV) of site-wide Emerson DeltaV DCS and PLC systems. This role is critical for ensuring that automated software logic meets both functional process requirements and stringent global regulatory standards (GAMP 5, 21 CFR Part 11).
Key Responsibilities
- Responsible for software design and data source configuration. Responsible for Emerson DeltaV batch execution, recipe authoring (S88 standards), and equipment module logic.
- Act as the SME for software validation. Author and execute Life Cycle documentation including URS, FS, DS, and IQ/OQ/PQ protocols.
- Manage connectivity and data flow between DeltaV and external software platforms (LIMS, SAP, AspenTech IP.21) using OPC UA/DA and ODBC interfaces.
- Perform code reviews and audit trail analysis. Lead investigations into software-related deviations and implement CAPA (Corrective and Preventive Actions).
- Ensure all automated systems comply with Data Integrity (ALCOA+) and cybersecurity protocols for industrial control systems.
Required Qualifications & Skills
- Degree in Computer Science, Software Engineering, or Instrumentation & Control.
- Minimum 6+ years in a GMP-regulated environment (Pharma/Biotech).
- Expert-level Emerson DeltaV, Siemens TIA Portal, or Allen Bradley RSLogix.
- Deep knowledge of GAMP 5 lifecycle and 21 CFR Part 11.
- Strong analytical mindset and ability to communicate complex software logic to non-technical stakeholders.
