job description
Join a Fortune 500 Biopharmaceutical MNC as a Senior Automation Engineer specializing in Validation & Compliance. This is a 9-month renewable contract offering a unique opportunity to work in a dynamic, high-impact environment in Bali, Indonesia.
In this role, you will drive automation initiatives to ensure regulatory compliance, optimize manufacturing processes, and enhance operational efficiency. You’ll collaborate with cross-functional teams to implement cutting-edge automation solutions while adhering to strict industry standards (e.g., GxP, FDA, EMA).
Ideal for professionals with a passion for biopharma automation, validation, and compliance, this position offers competitive compensation, exposure to global best practices, and the chance to contribute to life-saving therapies.
Responsibility
- Design, develop, and validate automation systems for biopharmaceutical manufacturing processes in compliance with GxP, FDA 21 CFR Part 11, and EU Annex 11.
- Lead IQ/OQ/PQ (Installation, Operational, Performance Qualification) activities for automated equipment and control systems.
- Collaborate with QA, Engineering, and IT teams to ensure seamless integration of automation solutions with existing workflows.
- Develop and maintain SOP (Standard Operating Procedures) and validation documentation (e.g., URS, FDS, DQ, FAT, SAT).
- Troubleshoot and resolve automation-related deviations, conducting root cause analysis (RCA) and implementing CAPA (Corrective and Preventive Actions).
- Support audits and inspections by regulatory bodies (e.g., FDA, EMA, PIC/S) with comprehensive compliance evidence.
- Optimize PLC, SCADA, and MES systems to improve process efficiency, data integrity, and traceability.
- Train end-users and maintenance teams on automated system operations and compliance requirements.
Qualifications
- Bachelor’s or Master’s degree in Electrical/Mechanical/Chemical Engineering, Automation, or related fields.
- Minimum 5+ years of experience in automation engineering within biopharmaceutical, pharmaceutical, or medical device industries.
- Proven expertise in validation (IQ/OQ/PQ) and compliance with GAMP 5, 21 CFR Part 11, and EU GMP.
- Hands-on experience with PLC (Siemens, Allen-Bradley), SCADA (Ignition, Wonderware), and MES systems.
- Strong knowledge of risk-based validation approaches (e.g., ASTM E2500) and data integrity principles (ALCOA+).
- Familiarity with Python, SQL, or LabVIEW for automation scripting and data analysis is a plus.
- Excellent problem-solving, communication, and project management skills.
- Certifications in Six Sigma, Lean Manufacturing, or ISA-88/95 are advantageous.