ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.
Job Scope :
The Sr. 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 Practices and Good Documentation Practices
Automation Control and Data Acquisition
EHS
Lab/Biological Safety
Gowning
Qualifications :
Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least 8+ years of related experience that provides direct scientific knowledge of automation systems operation and validation principles for computerized biologics production systems.
Expertise in IT Networking and industrial automation systems, such as Rockwell Automation (Allen Bradley RS Logix), Wonderware Archestra platform, Factory Talk View SE, TopView, Vaisala ViewLinc, Unicorn software, DeltaV, various Repligen and Thermo Scientific instruments is a plus.
Proven experience as an IT Automation Engineer or similar role.
Direct knowledge of the biologics process equipment, SCADA/control systems, and…