Sr. Manager of Facilities
ProBio · Hopewell, NJ · 4 days ago
On-siteManagement$120k–$150k/yrFull-time
Responsibilities
- Maintain 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.
- 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.
- 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.
- Ensure adherence to local, state, federal codes, building/fire codes, and industry standards. Establish safety inspections, audits, and implement corrective actions with EHS Department.
- 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.
- 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.
- 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.
- Lead initiatives to reduce reactive work, improve building systems up-time, and optimize costs while maintaining process consistency.
- Collaborate with Engineering, EHS, and Operations teams to integrate reliability strategies, risk-based asset management, and condition monitoring.
- Provide strong people leadership, developing a high-performing team through coaching, team building, performance assessment, skill development, and effective cross-team collaboration.
- 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.
- 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.
- Serve as Manufacturing’s Subject Matter Expert for applicable Change Controls. Liaison with Business, Quality Assurance, and IT Systems to coordinate the Change Control processes.
- Hands-on experience in Process Automation Engineering, including SCADA development, deployment and administration.
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.