Director, Process Engineering

Director Of Process Engineering

The Director of Process Engineering will lead the process engineering effort for multiple strategic projects. This role serves as the owner-side Design Authority for process engineering on major biopharmaceutical capital programs. This role provides strategic leadership, technical governance, and oversight of all process engineering activities supporting large-scale manufacturing facility projects. The incumbent is responsible for ensuring that process systems are designed, integrated, and implemented in alignment with corporate engineering standards, regulatory expectations, and operational requirements. The role provides technical oversight of A&E contractor engineering activities and ensures that core process engineering deliverables—including process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), cause and effect diagrams, process schematics, and operations philosophy documentation—meet the technical, safety, and operational standards required for pharmaceutical manufacturing facilities. As part of the project leadership team, the Director ensures effective integration of process design with utilities, automation, commissioning, qualification, and operational readiness activities. The role also supports corporate capital governance stage-gate processes, process safety management, and technology transfer integration with PDS&T, when required. The incumbent will report to Director, Engineering in the Operations Transformation organization.

Responsibilities include:

• Leading a team of subject matter experts to drive engineering schedules of selected A&E consultants
• Ensuring deliverables are reviewed, approved and issued for design or construction to ensure that the project procurement and construction activities proceed without any interruption
• Serving as the owner's senior process engineering leader for major capital projects.
• Providing leadership to the owner's process engineering team and coordinating with contractor engineering organizations.
• Establishing process engineering execution strategies and technical standards for the project.
• Ensuring alignment of process designs with manufacturing requirements, regulatory expectations, and corporate engineering standards.
• Driving cross-functional integration between engineering, operations, quality, and PDS&T teams.
• Acting as the Process Engineering Design Authority, responsible for technical approval and governance of key process engineering deliverables.
• Providing oversight and approval of critical engineering documents including Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), Process schematics and system architecture, Cause and Effect diagrams, control narratives and operations philosophy documentation
• Leading multidisciplinary design reviews to ensure completeness, operability, and compliance with project standards.
• Ensuring design consistency across engineering disciplines including process, mechanical, utilities, automation, and facility systems.
• Supporting corporate capital project governance and stage-gate review processes.
• Ensuring process engineering deliverables are completed to required maturity levels at each project phase
• Defining and overseeing process system architecture, system boundaries, and equipment integration.
• Ensuring process systems are effectively integrated with Utility systems, Automation and control systems, Facility infrastructure, Cleanroom and environmental systems
• Providing technical oversight for development and verification of process fluid lists and line lists.
• Ensuring proper classification of process streams and evaluate material compatibility, corrosion risks, and contamination risks associated with process fluids.
• Ensuring alignment between process fluid characteristics and material selection for piping, valves, and equipment.
• Providing governance and technical review for process piping design including Pipe sizing and hydraulic calculations, Pressure drop and flow rate analysis, Line classification and specifications
• Ensuring piping designs support process reliability, cleanability, maintainability, and sterility where applicable.
• Ensuring process systems meet corporate and regulatory process safety management (PSM) requirements including
• Providing oversight for process safety analyses including Relief valve sizing calculations, Overpressure protection analysis, Process hazard analysis (PHA), HAZOP facilitation and resolution
• Reviewing safety-critical calculations and engineering analyses.
• Leading development and approval of operations philosophy documentation defining system operation, control strategies, and operational boundaries.
• Ensuring process systems support safe startup, shutdown, maintenance, and cleaning activities.
• Integrating operational considerations into design including human factors, accessibility, and maintainability.
• Collaborating with operations and MSAT teams to ensure long-term operability of process systems.
• Supporting systemization and turnover to CQV teams by providing technical support during system startup and operational readiness activities.
• Leading resolution of process engineering issues identified during commissioning and qualification.
• Monitoring contractor performance, deliverables quality, and resource utilization.
• Ensuring efficient coordination between contractor teams and internal engineering resources.
• Overseeing engineering budgets and resource plans across the project lifecycle.
• Ensuring efficient utilization of both internal and contractor engineering resources.
• Supporting development of capital cost estimates and engineering schedules.
• Identifying and mitigating risks that could impact project cost or timeline.
• Contributing to and leading a high-performing project organization including program managers, engineering leads, construction managers, CQV leads, and project controls professionals.
• Fostering a culture of safety, accountability, collaboration, and operational excellence.

Qualifications include:

• BS, Engineering or equivalent technical degree; Master's degree in Engineering or MBA preferred
• 20+ years of experience as a Senior Engineering / Projects / Operations Leader across multiple technologies.
• Proven leadership experience in engineering of mega-capital projects ($500MM – $1B+)
• Deep knowledge of engineering systems in all disciplines in biopharmaceutical industry
• 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 include: ME&C, PDS&T, R&D, Procurement, Global Engineering, EHS, Facilities, AI and Digital Transformation, Government Affairs, External agencies including vendors, contractors, government agencies.

Additional Information:

• 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 short-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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

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Pay Range: $182000 - 346000 USD

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