Purpose:

The Associate Director of Utilities provides owner-side leadership and technical governance for the design, integration, and delivery of Utilities and associated infrastructure supporting large biopharmaceutical capital projects. This role serves as the Design Authority for Black and Clean utility systems, ensuring that the systems are designed to meet manufacturing requirements, GMP standards, reliability expectations, and regulatory compliance. The incumbent provides oversight of Engineering contractor’s design activities and ensures effective integration between process systems, HVAC, automation, process equipment and facility infrastructure. Key systems of responsibility include Chillers, compressors, steam boilers, cooling towers, Purified water, WFI, Clean Steam including the distribution systems required for pharmaceutical and biologics manufacturing capital projects of total value > $2B. The role also requires implementation of technology with AI and digital innovation teams such as the Factory of the Future.  The incumbent will report to Senior Director, Engineering in the Operations Transformation organization.            

Responsibilities

• Serve as the owner’s senior Utilities system technical leader
• Lead the owner’s Utilities team and provide technical oversight of Engineering contractor’s design activities related to black and clean utilities.
• Establish engineering standards and execution strategies for Utility systems
• Lead technical strategy and engineering oversight for Black utilities such as Plant steam, Chilled water, Cooling water, Compressed air, HVAC utilities, Glycol systems, Potable water, Vacuum systems, breathing air and Clean utilities such as Nitrogen and process gases, Purified Water (PW), Water for Injection (WFI), Clean steam, Clean compressed air, Process gases, CIP utility infrastructure
• Develop and maintain engineering standards, specifications, design guides, and best practices for utility systems.
• Ensure harmonization and consistency of utility system design across global capital projects and manufacturing sites.
• Provide technical leadership for selection, specification, integration, and lifecycle management of utility systems across all strategic capital projects.
• Review and approve engineering deliverables including equipment datasheets, Cause and Effect matrices, Control philosophy and narrative, P&IDs, utility system specifications, load and sizing calculations, piping, data sheets.
• Ensure consistency of instrumentation architecture and implementation across global projects and manufacturing sites.
• Support design reviews, HAZOPs, constructability reviews, FAT/SAT activities, and operational readiness assessments.
• Support project planning, budgeting, negotiation and procurement strategies, and schedule development for instrumentation packages.
• Review vendor submittals and ensure alignment with process, automation, cybersecurity, and GMP requirements.
• Partner with automation and process control teams to ensure proper integration between field instrumentation, PLC/DCS/SCADA platforms, and manufacturing execution systems.
• Support definition of control strategies, alarm management philosophy, and data integrity requirements.
• Ensure field devices and instrumentation networks align with digitalization and smart manufacturing initiatives.
• Ensure system design meets GMP, reliability, and operational requirements in addition to supporting contamination control, reliability and maintainability
• Lead instrumentation commissioning strategy and execution for process systems, clean utilities, and facility infrastructure.
• Support development and review of commissioning plans, test scripts, turnover packages, and startup procedures.
•  and digital systems leader.
• Define the automation architecture and digital strategy for the project.
• Lead the owner’s automation engineering team.
• Provide oversight for design and implementation of Distributed Control Systems (DCS), PLC-based equipment control systems, Batch automation systems, Supervisory Control and Data Acquisition (SCADA), Process control strategies
• Provide oversight for design and implementation of environmental monitoring systems and Building automation systems
• Ensure automation supports reliable manufacturing operations and regulatory compliance.
• Ensure compliance with data integrity and regulatory requirements.
• Oversee development of control narratives and cause-and-effect diagrams.
• Ensure integration between automation systems, equipment vendors, and process control systems.
• Ensure automation supports process control, safety interlocks, and operational efficiency.
• Ensure automation systems comply with corporate cybersecurity and GxP data integrity requirements.
• Implement secure and reliable automation architectures
• Support automation system testing and commissioning including system integration testing and operational readiness. Ensure automation systems support CQV activities.
• Drive transformation across all phases of the projects to deliver best-in-class technology, efficiency in execution to reduce the overall project line up to 20% from the baseline, introduce AI and digitalization in various aspects of project management and development.
• Monitor and control the cost and schedule of automation vendor driven programs including hardware and software to ensure adherence to project budgets and timeline
• Serve as the enterprise SME for utility system design, operation, commissioning, and lifecycle management.

Capital Project Execution:

• Provide technical leadership for utility scope on major greenfield and brownfield biopharmaceutical projects.
• Review and approve utility system deliverables including:
• PFDs and P&IDs
• Utility load calculations
• Equipment specifications
• System layouts
• Hydraulic calculations
• Control philosophies
• Equipment datasheets
• Turnover documentation
• Support project planning, budgeting, procurement, and schedule development for utility packages.
• Interface with EPCM firms, OEMs, contractors, and vendors to ensure compliance with company standards and project objectives.
• Participate in design reviews, HAZOPs, constructability reviews, and operational readiness assessments.

Clean Utility Systems Expertise:

• Provide technical oversight for generation, storage, and distribution systems for GMP clean utilities.
• Ensure clean utility systems meet applicable regulatory and industry requirements for pharmaceutical manufacturing environments.
• Support establishment of microbial control strategies, sanitary design principles, and contamination control measures.
• Review material selections, hygienic piping layouts, drainability, passivation requirements, and instrumentation strategies.
• Ensure utility system designs support validated and reliable manufacturing operations.

Commissioning, Qualification & Startup:

• Lead utility commissioning and startup activities for new and modified facilities.
• Support development and execution of:
• Commissioning plans
• Functional test procedures
• Startup protocols
• Turnover packages
• SAT/FAT activities
• Coordinate with CQV teams to ensure qualification readiness and successful system handover to operations.
• Troubleshoot startup and performance issues associated with utility systems and equipment.
• Ensure systems achieve required operational performance, reliability, and regulatory compliance.

Reliability, Sustainability & Operational Excellence:

• Promote utility system designs focused on reliability, maintainability, operational efficiency, and sustainability.
• Support energy management and utility optimization initiatives.
• Drive implementation of best practices for redundancy, resiliency, and lifecycle asset management.
• Analyze utility system performance and identify continuous improvement opportunities.

Compliance & Quality:

• Ensure utility systems comply with:
• GMP requirements
• FDA and global regulatory expectations
• ASME, ISA, ISPE, and applicable engineering codes
• Corporate engineering standards
• Support audit and inspection readiness activities.
• Ensure all work is executed in accordance with safety, quality, and environmental standards.