Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Job Summary:

We are seeking a highly skilled Control & Automation Specialist to support the design, implementation, and optimization of automation systems used in the manufacturing of medical devices. This role requires deep technical expertise in PLCs, SCADA, HMIs, and control systems, along with a strong understanding of FDA regulations, 21 CFR Part 11, and GMP-compliant automation solutions. The ideal candidate will play a key role in ensuring the efficiency, reliability, and compliance of automated production processes.

Key Responsibilities:

Automation Design & Implementation:

Develop and implement PLC-based control systems for medical device manufacturing equipment.Configure and program SCADA/HMI interfaces for process control and monitoring.Design and support integration of sensors, actuators, and control panels.Participate in FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and commissioning of automation systems.Support equipment validation activities (IQ/OQ/PQ) in collaboration with Quality and Validation teams.

System Support & Troubleshooting:

Provide technical support for troubleshooting automation-related issues during production.Optimize control strategies to improve equipment performance, reduce downtime, and enhance process reliability.Maintain accurate documentation for automation software, hardware changes, and system modifications.Ensure systems are maintained in validated state and compliant with regulatory requirements.

Compliance & Documentation:

Ensure all control systems and automation solutions comply with FDA, ISO 13485, GAMP 5, and 21 CFR Part 11 requirements.Create and maintain design specifications, risk assessments, software change control, and SOPs related to automation.Support audits and inspections by providing technical documentation and system traceability.

Collaboration & Continuous Improvement:

Work cross-functionally with R&D, Manufacturing, Quality, Validation, and IT teams.Recommend and implement automation improvements in support of lean manufacturing and Six Sigma initiatives.Evaluate and implement new technologies to enhance automation capabilities and data integration.

Qualifications:

Bachelor’s degree in engineering, sciences or a related field.3+ years of experience in automation/control engineering, preferably within the medical device, pharmaceutical, or regulated manufacturing industries.Hands-on experience with PLC platforms (e.g., Allen-Bradley, Siemens, Beckhoff).Proficiency with HMI/SCADA systems (e.g., FactoryTalk, Wonderware, Ignition).Knowledge of industrial communication protocols (e.g., Ethernet/IP, Modbus, OPC).Familiarity with validation requirements and documentation in regulated environments.Strong troubleshooting, analytical, and communication skills.

Preferred Qualifications / Certifications:

Experience with MES integration and data historians (e.g., OSIsoft PI, Aveva).Knowledge of robotics, vision systems, or motion control is a plus.Understanding of cybersecurity best practices for industrial control systems.GAMP 5, Six Sigma, or Lean Manufacturing certification is a plus.

Work Environment:

Combination of office, laboratory, and manufacturing environments.Must be able to work on the production floor and comply with cleanroom protocols where required.Occasional off-hours or weekend support may be needed during system commissioning or shutdowns.