The Automation Engineer is responsible for designing, implementing, and maintaining automated systems in the biopharmaceutical manufacturing environment. This role involves working at the intersection of engineering, technology, and biopharmaceutical processes, ensuring the efficient and compliant operation of automated equipment and systems.
RESPONSIBILITIES
System Design and Implementation
- Design and develop automation solutions for various Biopharma manufacturing processes, including production, packaging, and quality control.
- Collaborate with cross-functional teams to understand requirements and translate them into technical specifications.
- Select appropriate hardware and software components to achieve automation objectives.
- Oversee the installation and commissioning of automation systems, ensuring adherence to project timelines and budgets.
Maintenance and Optimization
- Monitor and maintain automated systems to ensure uninterrupted operation.
- Troubleshoot technical issues and implement corrective actions to minimize downtime.
- Conduct routine inspections and preventive maintenance activities to prolong equipment lifespan and enhance reliability.
- Identify opportunities for automation optimization and efficiency improvements.
- Provide technical guidance to automation technicians. Ensure the training records are kept up to date.
- Manage the cybersecurity requirements and work closely with IT team to implement a safe working environment free from cyber threats.
Regulatory Compliance
- Ensure that automation solutions comply with regulatory requirements, GMP (Good Manufacturing Practice) standards, and other relevant regulations.
- Participate in validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols and documentation.
- Keep up with of industry trends and regulatory updates to proactively address compliance issues.
Risk Management and Quality Assurance
- Conduct risk assessments of automated systems to identify potential hazards and implement risk mitigation strategies.
- Support quality assurance efforts by ensuring that automation processes meet specified quality standards.
- Investigate deviations or non-conformances related to automation systems and implement corrective and preventive actions.
Continuous Improvement
- Drive continuous improvement initiatives to enhance automation capabilities, efficiency, and cost-effectiveness.
- Collaborate with stakeholders to identify areas for process optimization and automation enhancements.
- Implement best practices and innovative technologies to stay at the forefront of automation in biopharmaceutical manufacturing.
REQUIREMENTS
- Bachelor’s or master’s degree in engineering (e.g., Electrical, Mechanical, Chemical, or Biomedical Engineering) or related field.
- A minimum of 8 years of experience in automation engineering, preferably within the biopharmaceutical or pharmaceutical industry.
- Adept knowledge of automation technologies, including PLCs, SCADA systems, software, Data warehouse like OSIPI and industrial networking protocols. Siemens PCS7
- Familiarity with regulatory requirements and standards governing biopharmaceutical manufacturing processes.
- Experience with test protocols and executions eg. IQ/OQ/PQ, test scripts with relevant key deliverables such as plan, report, deviation, change control and industry best practices etc.
- Experience in start-ups, commissioning & qualification (CSV) of Automation and process control systems.
- Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards
- Excellent problem-solving skills and ability to troubleshoot complex technical issues.
- Effective communication and teamwork abilities, with the capacity to collaborate with cross-functional teams.
- Attention to detail and commitment to safety, quality and compliance.
Reg No.: R2090579
EA License No.: 02C3423
Manpower Singapore
Lim Pey Chyi (Apple) - [email protected]
