Description

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, 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.

Responsibilities:

• 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.
• Facility Integrity: 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.
• Regulatory Compliance: Ensure adherence to local, state, federal codes, building/fire codes, and industry standards. Establish safety inspections, audits, and implement corrective actions with EHS Department.
• Budget & Capital Planning: Manage annual repair/maintenance budgets and oversee CAPEX projects to upgrade critical infrastructure and process automation systems. Lead the MRO (Maintenance, Repair & Operations) Program, including strategic purchasing, inventory management, critical spare parts planning, vendor negotiations, and cost optimization. Demonstrated ability to develop Business Case analyses, cost estimates / budgetary figures, project schedules that integrate multiple trades / disciplines, and hands on experience in managing project teams, executing project plans and ensuring on-time delivery within budget.
• Vendor & Spend Management: Oversee site utility supply and cost performance- including electricity, gas, water, and nitrogen-through effective budgeting, forecasting, contract management, and continuous cost‑reduction initiatives. Drive energy‑conservation and waste‑minimization programs to reduce utility consumption and annual spend Coordinate vendor service spend for PM, automated systems and break/fix activities to meet budget targets.
• Process Improvement: Lead initiatives to reduce reactive work, improve building systems up-time, and optimize costs while maintaining process consistency. Demonstrated competence in authoring, deployment and training delivery of policies, procedures and work instructions.
• Cross-Functional Leadership: Collaborate with Engineering, EHS, and Operations teams to integrate reliability strategies, risk-based asset management, and condition monitoring.
• Associate Management: Provide strong people leadership, developing a high-performing team through coaching, team building, performance assessment, skill development, and effective cross-team collaboration.
• Data & Compliance: Maintain accurate records and ensure data integrity for the administration and operation of process automation systems and supporting IT Systems (i.e., servers, clients, Active Directory, Domain Controllers, data backup processes and tools, cybersecurity processes, integrated Information Systems, etc), equipment maintenance, BOMs, spare parts lists, PLC Controllers, P&ID diagrams and process instruments calibration. Demonstrate working knowledge and practical interpretation of domestic / international regulations and industry standards, (FDA, cGMPs, ICH, EPA, and OSHA) for validation of equipment and automated systems, including applicable cGMP/GLP requirements, procedures, methods, and protocols for performance of assigned duties & responsibilities. Maintain comprehensive asset data, including equipment specifications, maintenance documentation, and full lifecycle histories to support decision-making, reliability programs, and regulatory compliance
• Process Automation Engineering: Develop appropriate Process Automation Strategies and Change Controls to enhance the operation and data integrity of Automated Systems (i.e., SCADA, PLC Alarm Notification, EMS, CMMS, bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and benchtop instruments used in PD Labs/QC operations, etc.) Recommend and integrate new bioprocess equipment. Liaison with Business, Quality Assurance, and IT Systems to coordinate the Change Control processes. Serve as Manufacturing's Subject Matter Expert for applicable Change Controls. Hands-on experience in Process Automation Engineering, including SCADA development, deployment and administration.
• Ability to prioritize and juggle multiple concurrent projects and day-to-day requests.

Qualifications:

• Bachelor of Science in Mechanical Engineering, Electrical Engineering, Computer Engineering, or related field of study with at least ten years of related experience that provides direct scientific knowledge of system automation principles and biologics production equipment/system, Master of Science in Information Systems is preferred.
• 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.
• 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 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.
• Analytical thinker with excellent problem-solving, prioritization and organizational skills; proactive problem identification skills for technical, organizational, and personnel issues; management and resolution of conflicting priorities; and ability to delegate and adapt to changing priorities and deadlines.
• Working experience as a project management with hands-on experience using project planning, execution, tracking, risk-mitigation and reporting tools.
• Demonstrated ability to interact with management in developing project objectives and site strategies; and advise management regarding technical opportunities and advances.

Pay range is estimated between $120k - $150k based on skill set and experience.

#PB

#AH

Benefits:

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

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.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.