Technical Expert Engineering Automation (Senior Engineer)
- Responsible for designing, implementing, and maintaining automated systems in the biopharmaceutical manufacturing environment.
- 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 5 years of experience in automation engineering, preferably within the biopharmaceutical or pharmaceutical industry.
- Excellent 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.
Lim Pey Chyi (Apple) - [email protected]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
