Job Opportunities API

About GenScript Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.   About ProBio: 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. 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: cGxP Applicable Corporate and Departmental Directives, Policies, and Procedures Good Manufacturing