Controls Engineer

Biosimilar Sciences PR LLC• Aguadilla, PR, PR, PR

5d•Onsite

About The Position

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies. It provides dedicated autonomous manufacturing capacity and interconnected infrastructure for development from early development and pre-clinical stages through clinical and commercial start. OcyonBio aims to create a workplace free of 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 across system design, commissioning, qualification, operation, and lifecycle support to ensure reliable controls and accurate, accessible process information. Scope includes PLCs, HMIs, SCADA, BMS, control logic, automation software, and associated process data systems. The role owns automation applications and control functionality. IT retains responsibility for site network infrastructure, enterprise software, and IT services; shared interfaces, infrastructure support, and cybersecurity activities are coordinated with IT. The position is based at CII George Sanders, Aguadilla Pueblo, Aguadilla, P.R. 00603. The engineer works with Engineering, Quality, Manufacturing, Maintenance, IT, vendors, and system owners to establish the site automation program, maintain controlled and validated systems, support production and facility systems, and plan upgrades and lifecycle support.

Requirements

Bachelor’s degree in Electrical, Controls, Automation, Computer, Chemical, or Mechanical Engineering, or a related engineering discipline.
Minimum three years of relevant industrial automation or process controls experience, including hands-on PLC and HMI work.
Hands-on proficiency in PLC programming and troubleshooting, HMI configuration, control logic, instrumentation, and industrial automation software.
Ability to interpret electrical schematics, piping and instrumentation diagrams, control narratives, and industrial communications architectures.
Working knowledge of BMS, SCADA, process data collection, alarm management, configuration control, and backup and recovery practices.
Understanding of regulated automation lifecycle practices, computerized system validation, change control, and data integrity.
Strong analytical, organizational, technical writing, and communication skills, with the ability to work independently and collaborate with IT, Quality, Manufacturing, and Engineering.
Proficiency in Microsoft Word, Excel, PowerPoint, and technical documentation tools.
Ability to sit, stand, and walk for extended periods; lift 25 pounds occasionally; and work in laboratories, cleanrooms, and manufacturing areas using required PPE.

Nice To Haves

Familiarity with 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 principles.
Experience in pharmaceutical, biologics, or other regulated manufacturing.
Aseptic manufacturing and facility start-up experience.
Experience with Rockwell Automation or Siemens platforms, BMS applications, and automation vendors or system integrators.

Responsibilities

Establish the site automation program, system inventory, criticality assessments, technical standards, and lifecycle support plans for manufacturing and engineering systems.
Develop SOPs and work instructions covering 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, I/O lists, interlocks, alarm settings, control narratives, and system interfaces.
Configure, program, troubleshoot, and optimize PLCs, HMIs, BMS, and related control applications within approved change control and qualification requirements.
Support automated manufacturing equipment, 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 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.
Establish controls for process data collection, trends, alarm and event histories, reports, and interfaces to keep records 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 validated state before implementation.
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 with Engineering, Quality, and Validation.
Support computerized system validation and applicable cGMP, electronic records, electronic signatures, and data integrity requirements.
Assess automation changes, deviations, and corrective and preventive actions; document testing and maintain approved configurations and the validated state.
Serve as the automation subject matter expert during audits and inspections; support periodic system reviews and closure of identified gaps.
Develop automation obsolescence, upgrade, spare parts, and service support plans; identify risks from unsupported hardware or software and unavailable source code.
Coordinate automation vendors and integrators, define scopes of work, review deliverables, and support budgets and procurement for controls projects.
Track recurring failures, automation downtime, backup and recovery readiness, and improvement actions; execute work under site safety and cleanroom requirements.