Sr. Manager of Facilities

Minimum 15 years in engineering leadership in a regulated manufacturing environment, with strong production, process automation, IT systems, and maintenance backgrounds.

Direct knowledge of the design, commissioning, qualification, operation and maintenance of biologics facility infrastructure, process equipment, benchtop instruments, SCADA, BAS, Fire Safety and Security, and IT systems.

Expertise in scientific / technical subject areas – Equipment Qualification, Computer System Validation, Cleaning Validation, SCADA system architecture, Biotech Process Equipment/Systems, Infrastructure IT systems, Cybersecurity processes.

Expertise in Rockwell Automation (Allen Bradley) programming software and Wonderware SCADA Systems.

Familiarity with CDMO platform technologies to advance the promise of cell and gene therapies from process development to clinical and commercial-scale manufacturing for plasmid DNA and viral vectors is a plus.

Demonstrated ability to interact with management in developing project objectives and site strategies; and advise management regarding technical opportunities and advances.

Maintenance & Reliability:

Implement processes for designing, scheduling, and executing preventive (PM) and non-routine maintenance (NRM) programs for facilities equipment and systems using CMMS tools.

Oversee corrective actions, emergency repairs, and 24/7 operational coverage.

Experience with BAS, HVAC, electrical, plumbing, refrigeration, and cGMP environments.

Oversee the maintenance of building, grounds, and utilities, and associated equipment to ensure uptime, reliability, and compliance for facility size 128,000-square-foot or more.

Manage all Instrumentation & Electrical (I&E) Systems, overseeing installation, commissioning, upgrades, compliance, and ongoing maintenance to ensure system integrity and safety.

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

Position Overview:

This role leads Facility Infrastructure, Building Equipment Maintenance, and Process Automation Engineering functions, ensuring facilities, equipment, process instruments and automated systems operate efficiently, safely, and in compliance with regulatory standards. This role integrates maintenance, calibration and process automation strategy/technology to optimize Facility Operations performance, reduce downtime, and support continuous improvement. The scope of the responsibilities includes directing the initial installation, ongoing building maintenance, change controls, and retirement of equipment and process automated systems. This candidate will also direct and oversee Associates who responsible for critical systems used in Facility Operations such as SCADA, Labs, QC, BAS, EMS, Fire, Card Access, CMMS (Maximo), and more.