Job Description

Automation / Systems Engineer

Overview

Support the delivery of major capital projects including but not limited to aseptic filling line, compounding room, and clean utility upgrades. The role will provide automation and computerized systems expertise across design review, vendor oversight, system integration, commissioning, qualification, and start-up activities, ensuring successful deployment of compliant and reliable automation solutions.

Key Responsibilities & Competencies

• Lead automation and OT activities for filling, compounding, and clean utility projects.
• Coordinate automation vendors, integrators, and project stakeholders through design and implementation phases.
• Review and approve automation lifecycle documentation including URS, FDS, SDS, FAT, SAT, IQ, OQ, and commissioning deliverables.
• Support integration of PLC, SCADA, DCS, utility, manufacturing, MES, historian, and enterprise systems.
• Provide technical oversight during FAT, SAT, commissioning, qualification, and operational readiness activities.
• Troubleshoot automation, network, and system integration issues to support successful project delivery and startup. Ideal Experience
• Proven experience delivering automation projects within pharmaceutical or biopharmaceutical manufacturing facilities.
• Strong background in PLC, SCADA, DCS, OT networks, and system integration.
• Demonstrated CQV and Computer System Validation experience within a GxP environment.
• Experience managing equipment vendors and system integrators.
• Knowledge of ISA-88, ISA-95, data historians, MES, and manufacturing system architectures.
• Ability to work independently while coordinating effectively with Engineering, Operations, CQV, QA, and IT/OT teams.