Associate Director, Utilities Engineering

Responsibilities

• Serve as the owners senior Utilities system technical leader
• Lead the owners Utilities team and provide technical oversight of Engineering contractors 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 owners 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
• Ensure 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
• 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
• Support the owners clean utility systems team
• 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
• 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
• 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
• 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

Qualifications

• BS, in Engineering or equivalent technical degree; Masters degree in Engineering or MBA preferred
• 12+ years of experience as a process lead across multiple technologies
• Proven leadership experience in automation projects to support mega-capital projects ($500MM $1B+)
• Deep knowledge of automation systems, codes and architecture
• Proven inclusive management and leadership capabilities of large cross-functional teams and the ability to effectively interact and communicate with senior leadership and executives from strategic partners and authorities
• Demonstrated experience managing Engineering contractors and global equipment vendors
• Results-oriented leadership with outstanding negotiation skills and risk based decision making is required
• Ability to mentor and develop next generation of leaders