Automation Engineer, GMP

ProBio, a subsidiary of GenScript, has a one stop biopharmaceutical R&D and production platform, mainly dedicated to cell and gene therapy (CGT) drugs, vaccine and biopharmaceutical discovery, antibody protein Provides end-to-end CDMO services from target development to commercial production. GenScript has established companies in the United States, the Netherlands, South Korea, Shanghai, Hong Kong, Nanjing and other places to serve global customers. Since October 2017, it has assisted customers in the United States, Europe, Asia Pacific and other regions to obtain more than 50 IND approvals.

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, TopView, Vaisala ViewLinc, Unicorn software, DeltaV, 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 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.
• 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

Please note that this role is based fully onsite in Pennington, New Jersey. The estimated salary range is $90,000 - $120,000 annually.

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