
Director, Process Engineering
BioSpace, north chicago, il, United States
Purpose
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. It provides strategic leadership, technical governance, and oversight of all process engineering activities supporting large‑scale manufacturing facility projects, ensuring alignment with corporate engineering standards, regulatory expectations, and operational requirements. The Director also oversees A&E contractor engineering activities and ensures that core process engineering deliverables—such as process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), cause and effect diagrams, process schematics, and operations philosophy documentation—meet the required technical, safety, and operational standards. Additionally, the Director integrates process design with utilities, automation, commissioning, qualification, and operational readiness activities, supports corporate capital governance stage‑gate processes, process safety management, and technology transfer integration with PDS&T when required. The incumbent reports to the Director of Engineering in the Operations Transformation organization.
Responsibilities
- Lead a team of subject‑matter experts to drive engineering schedules of selected A&E consultants
- Ensure deliverables are reviewed, approved and issued for design or construction to avoid interruptions in procurement and construction activities
- Serve as the owner’s senior process engineering leader for major capital projects
- Provide leadership to the owner’s process engineering team and coordinate with contractor engineering organizations
- Establish process engineering execution strategies and technical standards for the project
- Ensure alignment of process designs with manufacturing requirements, regulatory expectations, and corporate engineering standards
- Drive cross‑functional integration between engineering, operations, quality, and PDS&T teams
- Act as the Process Engineering Design Authority, responsible for technical approval and governance of key process engineering deliverables
- Provide oversight and approval of critical engineering documents including PFDs, P&IDs, process schematics, system architecture, cause and effect diagrams, control narratives, and operations philosophy documentation
- Lead multidisciplinary design reviews to ensure completeness, operability, and compliance with project standards
- Ensure design consistency across engineering disciplines—process, mechanical, utilities, automation, and facility systems
- Support corporate capital project governance and stage‑gate review processes
- Ensure process engineering deliverables are completed to required maturity levels at each project phase
- Define and oversee process system architecture, system boundaries, and equipment integration
- Ensure process systems are effectively integrated with utility systems, automation and control systems, facility infrastructure, cleanroom, and environmental systems
- Provide technical oversight for development and verification of process fluid lists and line lists
- Ensure proper classification of process streams and evaluate material compatibility, corrosion risks, and contamination risks associated with process fluids
- Align process fluid characteristics with material selection for piping, valves, and equipment
- Govern and review process piping design, including pipe sizing, hydraulic calculations, pressure‑drop and flow‑rate analysis, and line classification and specifications
- Ensure piping designs support process reliability, cleanability, maintainability, and sterility where applicable
- Ensure process systems meet corporate and regulatory process safety management (PSM) requirements, including relief valve sizing, overpressure protection analysis, process hazard analysis (PHA), HAZOP facilitation and resolution
- Lead development and approval of operations philosophy documentation defining system operation, control strategies, and operational boundaries
- Ensure process systems support safe startup, shutdown, maintenance, and cleaning activities
- Integrate operational considerations into design—human factors, accessibility, and maintainability
- Collaborate with operations and MSAT teams to ensure long‑term operability of process systems
- Support systemisation and turnover to CQV teams by providing technical support during system startup and operational readiness activities
- Lead resolution of process engineering issues identified during commissioning and qualification
- Monitor contractor performance, deliverables quality, and resource utilisation
- Ensure efficient coordination between contractor teams and internal engineering resources
- Oversee engineering budgets and resource plans across the project lifecycle
- Support development of capital cost estimates and engineering schedules
- Identify and mitigate risks that could impact project cost or timeline
- Contribute to and lead a high‑performing project organization, including program managers, engineering leads, construction managers, CQV leads, and project controls professionals
- Foster a culture of safety, accountability, collaboration, and operational excellence
Qualifications
- BS in Engineering or equivalent technical degree; Master’s degree in Engineering or MBA preferred
- 20+ years of experience as a senior engineering/project/operations leader across multiple technologies
- Proven leadership experience in engineering of mega‑capital projects ($500 MM–$1 B+)
- Deep knowledge of engineering systems in all disciplines within the biopharmaceutical industry
- Inclusive management and leadership capabilities for large cross‑functional teams and the ability to interact and communicate effectively 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
- Ability to mentor and develop the next generation of leaders
- Travel within the US; outside the US for reviews, workshops, or visits to vendor facilities will be required
Key Stakeholders
- ME&C
- PDS&T
- R&D
- Procurement
- Global Engineering
- EHS
- Facilities
- AI and Digital Transformation
- Government Affairs
- External agencies—including vendors, contractors, government agencies
Benefits
- Paid time off (vacation, holidays, sick leave)
- Medical, dental, and vision insurance
- 401(k) plan for eligible employees
- Short‑term incentive programs
Equal Employment Opportunity
AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. We provide reasonable accommodations for qualified candidates with disabilities.
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