Automation Engineer (Pharma / Medical Device)

Position Overview We are seeking a motivated Automation Engineer with approximately 2 years of hands-on experience working with Programmable Logic Controllers (PLCs) in the pharmaceutical or medical device industry . The successful candidate will play a key role in supporting automation systems, ensuring compliance with regulatory standards, and driving process improvements across manufacturing operations Key Requirements: Design, program, and troubleshoot PLC-based automation systems for production equipment. Support installation, commissioning, and validation of automated systems in compliance with GMP and FDA regulations. Collaborate with cross-functional teams (Engineering, Quality, Manufacturing) to ensure automation solutions meet operational and regulatory requirements. Understand computerised system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11) and industry best practice documents / standards (e.g., GAMP5, ISA 88, ISA 95). Perform routine maintenance, upgrades, and modifications to automation systems to improve efficiency and reliability. Document automation processes, changes, and validation activities in accordance with industry standards. Assist in root cause analysis and corrective actions for equipment and system failures. Contribute to continuous improvement initiatives by identifying opportunities for automation enhancements. Qualifications Bachelor’s degree in Electrical Engineering, Automation, Mechatronics, or related field. Minimum of 2 years of experience working with PLCs (Siemens, Allen-Bradley, or similar) in a regulated pharmaceutical or medical device environment. Familiarity with GMP regulatory requirements and SDLC. Strong troubleshooting and problem-solving skills. Preferred Skills Experience with SCADA, HMI, or MES systems. Knowledge of validation protocols (IQ/OQ/PQ). Exposure to robotics or advanced automation technologies. Why Join ORKA: Work that Matters: Support clients bringing innovative and life saving solutions to the population. Career Development: Build a consulting career in a professional consulting company with Life Sciences focus. Professional Environment: Work with similar professionals possessing Intelligence, Resourcefulness, Loyalty and Teamwork characteristics. Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.