Automation Engineer, GMP

About GenScript GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About Pro Bio Pro Bio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers.

Pro Bio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.

The Automation Engineer is responsible for administration and management of the site’s automation systems, including Supervisory Control and Data Acquisition (SCADA) system, PLCs, notification systems and computerized QC Lab instruments. The scope of the responsibilities includes the initial installation, ongoing maintenance, periodic back-up, change control, validation, and retirement of systems.

The incumbent works cross-functionally with internal departments including Information Technology, Manufacturing, Facilities & Engineering, Quality Control, and Quality Assurance, as well as external resources/vendors to maintain the site’s automation systems. The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• Work closely with stakeholders to understand and fulfill system requirements and improve the quality of automated processes.
• Collaborate with stakeholders, including Area Managers, System Owners, and System Users to ensure successful onboarding, use and retirement of automation systems.
• Develop appropriate Validation Protocols, Reports, and Lifecycle documents.
• Execute Validation Protocols and collecting test evidence.
• Create and improve Administration SOPs of automation systems.
• Monitor integrity, availability, performance and operability of automation systems.
• Identify, investigate and correct technical issues, including performing root cause analysis for production errors.
• Make adjustments, enhancements and applying patches or upgrades as required for automation systems, while adhering to the Change Control process.
• Understand network operations, system operations, and Cloud-based systems.
• Administer user access management.
• Ensure compliance with applicable regulatory standards.
• Maintain up-to-date knowledge of current technology trends, programming languages, and automation best practices for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and QC instruments.
• Author appropriate Change Controls and Test Scripts and serve as the Subject Matter Expert for applicable technical changes in automation systems.
• Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT).
• Liaison with Business, Quality Assurance, Managed Services, and IT to coordinate the Change Request processes.
• Training:
  • cGxP
  • Applicable Corporate and Departmental Directives, Policies, and Procedures
  • Good Manufacturing Practices and Good Documentation Practices
  • Automation Control and Data Acquisition
  • EHS
  • Lab/Biological Safety
  • Gowning

• Expertise in IT Networking and industrial automation systems, such as Rockwell Automation (Allen Bradley RS Logix), Wonderware Archestra platform, Top View, Vaisala View Linc, Unicorn software, Delta
  
  V, various Repligen and Thermo Scientific instruments is a plus.
• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least 5-7 years of related experience that provides…