Associate Director, Utilities Engineering

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 contractors 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 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
• 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.

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
• Travel within the US outside the US for reviews/workshops/visits to vendor facilities will be required

Key Stakeholders: ME&C PDS&T R&D Procurement Global Engineering EHS Facilities AI and Digital Transformation.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 
• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time