AUTOMATION SYSTEMS ENGINEER

ENTERPRISE SOFTWARE SOLUTIONS PRIVATE LIMITED

Execute commissioning and qualification activities for process equipment and associated systems.
Develop, review, and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform DeltaV functional testing and support system integration and validation activities.
Verify equipment and system operation against User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and applicable GMP requirements.
Coordinate with Engineering, Automation, Validation, Quality Assurance, and Operations teams to identify and resolve technical issues during project execution.
Review, prepare, and approve commissioning, qualification, and validation documentation in accordance with site procedures and regulatory expectations.
Support system startup, troubleshooting, commissioning readiness reviews, and handover to operations.
Ensure all validation and qualification activities are conducted in compliance with company procedures, quality standards, and applicable regulatory guidelines.
Participate in risk assessments, deviation investigations, change controls, and CAPA activities related to validated systems.
Maintain accurate and complete validation records to support regulatory inspections and audits.

Bachelor's Degree in Engineering, Automation, Instrumentation, Electrical, Electronics, or a related technical discipline.
3–8 years of experience in Computer System Validation (CSV), Commissioning & Qualification, or Validation within pharmaceutical, biotechnology, or life sciences industries.
Hands-on experience with DeltaV DCS systems and associated automation platforms.
Strong knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and data integrity requirements.
Experience in developing and executing IQ, OQ, PQ, FAT, SAT, and validation protocols.
Familiarity with process equipment, utility systems, and manufacturing automation systems.
Excellent technical writing, documentation, and communication skills.

Experience in greenfield or brownfield pharmaceutical projects.
Knowledge of MES, SCADA, PLC, Historian, and integrated automation systems.
Exposure to qualification of computerized systems in sterile, biologics, or pharmaceutical manufacturing facilities.
Ability to manage multiple priorities and work effectively in cross-functional project teams.