AUTOMATION SYSTEMS ENGINEER

Job Summary

The Engineer is responsible for planning, executing, and documenting commissioning, qualification, and validation activities for process equipment, automation systems, and associated computerized systems within a regulated GMP environment. The role involves supporting system lifecycle activities, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to achieve successful project delivery and operational readiness.

Key Responsibilities

• 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.

Required Qualifications

• Bachelor's Degree in Engineering, Information Technology, Electronics, or a related technical discipline.
• 4+ 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.

Preferred Qualifications

• 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.

Key Competencies

• Computer System Validation (CSV)
• Commissioning & Qualification
• DeltaV Functional Testing
• Technical Documentation
• Problem Solving & Troubleshooting
• Cross-Functional Collaboration