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.
