Purpose:

The Associate Director, Instrumentation will serve as the technical authority and subject matter expert (SME) for field instrumentation and control systems supporting large-scale biopharmaceutical capital projects. This role is responsible for establishing engineering standards, leading instrumentation design strategies, ensuring compliant implementation, and overseeing commissioning and startup activities across major GMP manufacturing facilities and utility systems. The position will partner with internal engineering, automation, operations, quality, validation, and external EPCM firms to deliver safe, compliant, reliable, and maintainable process instrumentation solutions aligned with business objectives, regulatory expectations, and lifecycle asset management principles. The role also supports 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 engineering leader and design authority for field instrumentation and control devices.
• Lead the owner’s instrumentation team and provide technical oversight of Engineering contractor’s design activities related to instrumentation and control.
• Establish engineering standards and execution strategies for field instruments and control devices.
• Provide technical leadership for instrumentation selection, specification, integration, and lifecycle management across all strategic capital projects.
• Ensure consistency of instrumentation architecture and implementation across global projects and manufacturing sites.
• Review and approve instrumentation deliverables including Instrument datasheets, Instrument indexes, I/O List, Loop drawings, Cause and Effect matrices, Control philosophy and narrative, P&IDs, Network communication and architecture drawings, panel arrangement, cabling and tray/support specifications, shielding, ATEX ratings, control valve sizing and calculations, valve calculations, data sheets.
• 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.
• Ensure instrumentation systems are specified, procured, installed, calibrated, tested, and documented in accordance with GMP, ISA, IEC, NEMA and engineering standards.
• Coordinate with CQV teams to support qualification readiness and successful handover to operations.
• Troubleshoot startup and operational issues related to instrumentation and controls.

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.