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 ProBio

ProBio 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 (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.

Job Scope:

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.

Responsibilities:

• • 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:

  • o cGxP
    o Applicable Corporate and Departmental Directives, Policies, and Procedures
    o Good Manufacturing Practices and Good Documentation Practices
    o Automation Control and Data Acquisition
    o EHS
    o Lab/Biological Safety
    o Gowning

Qualifications:

• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least 5-7years of related experience that provides direct scientific knowledge of automation systems operation and validation principles for computerized biologics production systems.
• Proven experience as an IT Automation Engineer or similar role.
• Direct knowledge of the biologics process equipment, SCADA/control systems, and supporting IT networking infrastructure.
• Expertise in scientific / technical subject areas – Equipment Qualification, Computer System Validation, SCADA system architecture, Biotech Process Equipment/Systems.
• Proficient in use of electronic systems, such as Microsoft Office, various specialized software including process documentation Veeva Vault, Material Management (SAP), Computerized Maintenance Management System (Maximo), Building Automation System (BAS).
• Knowledge of domestic / international regulatory guidelines / compendia and industry standards (FDA, ICH, USP and EMEA guidelines) for validation of computerized equipment and automation systems, including but not limited to 21 CFR Part 11, EU Eudralex Annex 11 and GAMP 5.
• Expertise in IT Networking and industrial automation systems, such as Rockwell Automation (Allen Bradley RS Logix), Wonderware Archestra platform, TopView, Vaisala ViewLinc, Unicorn software, DeltaV, various Repligen and Thermo Scientific instruments is a plus.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Comfort with collaboration, open communication, reaching across functional borders and being proactive.
• A strong focus on business outcomes.
• Ability to prioritize and juggle multiple concurrent projects and day-to-day requests

#PB

#LW

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.