Sr. 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 Sr. Automation Engineering is responsible for administration of the Supervisory Control and Data Acquisition (SCADA) system, and management of automation systems installed on the GMP manufacturing equipment and instruments. The scope of the responsibilities includes the initial installation, ongoing maintenance, periodic back-up, change control, validation, and retirement of systems. This candidate will also understand and support additional GxP systems such as BAS, Maximo, and more.
The incumbent works cross-functionally with internal departments including Manufacturing, Facilities & Engineering, and Quality Assurance and external resources to maintain the SCADA. BAS, Maximo and other GMP manufacturing systems. The person supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Responsibilities:

• Perform GMP / GLP Activities
• SCADA, BAS, Maximo, and other automation engineering Systems Administration

• Monitoring of system performance and operability
• Develop appropriate Change Controls to enhance systems and operation
• System Modifications per Change Control
• Develop appropriate Validation Protocols, Reports, and Life-Cycle documents
• Execution of Validation Protocols

• Automation Systems Management

• • Develop appropriate automation for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and benchtop instruments
  • Author appropriate Change Controls and Test Scripts and serve as Manufacturing's Subject Matter Expert for applicable changes
  • Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT)
  • Ability to prioritize and juggle multiple concurrent projects and day-to-day requests.
  • Liaison with Business, Managed Services, and IT to coordinate the IT Change Request processes
  • Maintain current knowledge base of solutions and work with Managed Services sustainment teams to facilitate technical break / fixes.

• Knowledge of domestic / international regulatory guidelines / compendia, (FDA, ICH, USP and EMEA guidelines) for validation of equipment and systems.
• Knowledge of applicable cGMP/GLP requirements, procedures, methods, and protocols for performance of assigned duties & responsibilities.
• Training
  • cGMP training
  • Applicable Corporate and Departmental Directives, Policies, and Procedures
  • Good Manufacturing Practices and Good Documentation Practices
  • QA Quality General
  • Hopewell Biologics Manufacturing General/All
  • HBM Automation Control and Data Acquisition
  • Engineering EHS Training
  • Lab/Biological Safety EHS Training
  • Hopewell Biologics Manufacturing Gowning

Qualifications:

• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least ten years of related experience that provides direct scientific knowledge of system automation validation principles and biologics production equipment/systems.
• Direct knowledge of the biologics process equipment, SCADA/control systems, and validation practices
• Expertise in scientific / technical subject areas - Equipment Qualification, Computer System Validation, Cleaning Validation, SCADA system architecture, Biotech Process Equipment/Systems
• Proficient in use of electronic systems- Microsoft Office, various specialized software including process documentation Veeva Vault, Material Management (SAP), Computerized Maintenance Management System (Maximo), Building Automation System (BAS).
• Expertise in Rockwell Automation (Allen Bradley) programming software and Wonderware SCADA Systems.
• Familiarity with OSI Pi a plus.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

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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.