Automation Engineer, GMP

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002 with a presence in North America, Europe, Greater China, and Asia Pacific. Its businesses include a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy, all driven by leading gene synthesis technology.

Pro Bio provides end‑to‑end CDMO services from drug discovery to commercialization, offering proactive strategies and efficient processes in cell and gene therapy, vaccine, biologics discovery, and antibody protein drug development. Its full cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical and commercial manufacturing.

The Automation Engineer is responsible for the administration and management of the site’s automation systems, including the Supervisory Control and Data Acquisition (SCADA) system, PLCs, notification systems, and computerized QC lab instruments. Duties include installation, maintenance, backup, change control, validation, and retirement of these systems, working cross‑functionally with IT, Manufacturing, Facilities & Engineering, Quality Control, and Quality Assurance, as well as external vendors.

• 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 Users, to ensure successful onboarding, use, and retirement of automation systems.
• Develop appropriate Validation Protocols, Reports, and Lifecycle documents.
• Execute Validation Protocols and collect test evidence.
• Create and improve Administration SOPs for automation systems.
• Monitor integrity, availability, performance, and operability of automation systems.
• Identify, investigate, and correct technical issues, performing root‑cause analysis for production errors.
• Make adjustments, enhancements, and apply patches or upgrades as required, following 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 SME for applicable technical changes in automation systems.
• Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT).
• Liaison with Business, QA, 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, Top View, Vaisala View Linc, Unicorn software, Delta
  
  V, and various Repligen and Thermo Scientific instruments.
• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field with 5-7 years of relevant experience, providing direct scientific knowledge of automation systems operation and validation principles for computerized bioprocess equipment.
• Proven experience as an IT Automation Engineer or similar role.
• Direct knowledge of biologics process equipment, SCADA/control systems, and supporting IT networking infrastructure.
• Expertise in equipment qualification, computer system validation, SCADA architecture, and biotech process equipment/systems.
• Proficiency with electronic systems such as Microsoft Office, Veeva Vault, SAP, Maximo, and BAS.
• Knowledge of domestic/international regulatory guidelines and industry standards (FDA, ICH, USP, EMEA) for validation of computerized equipment, including 21 CFR Part 11, EU Eudralex Annex 11, and GAMP 5.
• Analytical thinker with excellent problem‑solving…