Controls Engineer

Job Description

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.

OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued.

The Controls Engineer establishes and manages the site's automation and process control systems, standards, and procedures for manufacturing equipment, facilities, and utilities. The role provides hands-on technical expertise throughout system design, commissioning, qualification, operation, and lifecycle support to ensure reliable controls and accurate, accessible process information.

Scope includes programmable logic controllers (PLCs), human-machine interfaces (HMIs), supervisory control and data acquisition (SCADA), building management systems (BMS), control logic, automation software, and associated process data systems. The role owns the automation application and control functionality. Information Technology (IT) retains responsibility for site network infrastructure, enterprise software, and IT services; shared interfaces, infrastructure support, and cybersecurity activities are coordinated with IT.

Place of Performance

CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. *.

Key Responsibilities

Automation Program Development and Site Start Up

· Establish the site automation program, system inventory, criticality assessments, technical standards, and lifecycle support plans for manufacturing and engineering systems.

· Develop standard operating procedures (SOPs) and work instructions for automation changes, configuration and version control, access administration, backups, recovery, alarm management, and troubleshooting.

· Create and maintain controlled repositories for PLC programs, HMI applications, BMS configurations, recipes, software versions, licenses, and vendor documentation.

· Define automation requirements and review control designs, sequences of operation, input/output lists, interlocks, alarm settings, control narratives, and system interfaces.

Control Systems Engineering and Operational Support

· Configure, program, troubleshoot, and optimize PLCs, HMIs, BMS, and related control applications within approved change control and qualification requirements.

· Support automated manufacturing equipment, heating, ventilation and air conditioning (HVAC), critical utilities, and other process control systems; diagnose faults across instruments, controllers, actuators, and application interfaces.

· Manage control sequences, operating parameters, recipes, alarms, permissives, and interlocks in coordination with system owners; verify safe failure and restart behavior.

· Lead automation root-cause investigations and implement corrective actions to improve reliability, availability, and process performance.

· Provide technical support and training to Manufacturing, Engineering, and Maintenance personnel; coordinate vendor escalation and planned or urgent automation interventions.

Process Data and Automation System Administration

· Establish controls for process data collection, trends, alarm and event histories, reports, and interfaces so records remain complete, accurate, retrievable, and traceable.

· Define application user roles, permissions, audit trail settings, time synchronization needs, and data retention requirements with Quality and system owners; coordinate implementation with IT as applicable.

· Establish and verify backup and restoration of control programs, configurations, and applicable process records; develop and test recovery plans with IT and vendors.

· Coordinate industrial communications, remote vendor access, patches, and cybersecurity controls with IT; assess effects on process operation and the validated state before implementation.

Commissioning Qualification and Quality Support

· Support factory and site acceptance testing, commissioning, and qualification of automated systems, including control logic, alarms, interlocks, data handling, and recovery functions.

· Prepare or review user requirements, functional specifications, risk assessments, test protocols, and traceability documents in collaboration with Engineering, Quality, and Validation.

· Support computerized system validation and applicable current Good Manufacturing Practice (cGMP), electronic records, electronic signatures, and data integrity requirements.

· Assess automation changes, deviations, and corrective