Automation Engineer

Job Title:

Automation Engineer – Delta

V (Pharmaceutical Manufacturing)

We are seeking an experienced Automation Engineer with strong expertise in Emerson Delta

V Distributed Control Systems (DCS) to support pharmaceutical manufacturing operations. This role is responsible for the design, implementation, validation, maintenance, and continuous improvement of automation systems in a GMP-regulated environment. The ideal candidate will have experience supporting batch processes, regulatory compliance requirements, and validated control systems.

• Design, configure, and maintain Emerson Delta
  
  V DCS for pharmaceutical manufacturing processes (e.g., upstream, downstream, fill/finish, utilities).
• Develop and modify:
  • Control modules and equipment modules
  • Batch recipes and phases (ISA-88 compliant)
  • HMI graphics and alarm configurations
• Author and review automation documentation including:
  • Functional Specifications (FS)
  • Design Specifications (DS)
  • Configuration Specifications
  • Test protocols (FAT, SAT, IQ, OQ)
• Execute and support system validation activities in compliance with FDA, GMP, and GAMP 5 guidelines.
• Support deviation investigations, CAPAs, and change control processes.
• Provide technical troubleshooting and root cause analysis for process and automation issues.
• Support Delta
  
  V system upgrades, patches, backups, and lifecycle management.
• Integrate Delta
  
  V with related systems (e.g., PLCs, SCADA, historians, LIMS, MES).
• Ensure data integrity and cybersecurity compliance (21 CFR Part 11).
• Participate in audits and regulatory inspections as automation SME.
• Provide on-call or after-hours support as needed.

• Bachelor’s degree in Electrical, Chemical, Mechanical, or Computer Engineering (or related field).
• 3–5+ years of hands‑on Delta
  
  V configuration experience in a pharmaceutical or GMP‑regulated environment.
• Strong knowledge of:
  • Emerson Delta
    
    V Control Studio and Explorer
  • Batch (ISA-88) configuration
  • Alarm management and trending
  • System security and user management
• Experience with validation lifecycle (IQ/OQ/PQ) and change management processes.
• Working knowledge of:
  • 21 CFR Part 11
  • GAMP 5
  • Data integrity principles (ALCOA+)
• Ability to read and interpret P&IDs and process control narratives.
• Strong troubleshooting, documentation, and communication skills.

• Experience with Syncade MES integration.
• Knowledge of utilities systems (WFI, clean steam, HVAC, CIP/SIP).
• Experience with virtualization (VMware) and server infrastructure.
• Familiarity with cybersecurity standards (ISA/IEC 62443).
• Experience supporting capital projects or facility expansions.
• Strong understanding of GMP compliance and validation requirements
• Technical expertise in batch process control
• Analytical and problem‑solving skills
• Attention to detail and documentation accuracy
• Ability to work cross‑functionally with QA, Validation, Manufacturing, and Engineering