Director, Process Engineering
AbbVie
2 months ago
Remote friendly (North Chicago, IL)
United States
Operations
Purpose:
- Lead process engineering for multiple strategic biopharmaceutical capital projects; act as owner-side Design Authority and provide technical governance/oversight of process engineering activities for large-scale manufacturing facility projects.
Responsibilities:
- Lead a team of SME to drive A&E consultant engineering schedules.
- Ensure process engineering deliverables are reviewed, approved, and issued for design/construction to avoid project interruption.
- Serve as owner’s senior process engineering leader; provide leadership and coordinate with contractor engineering organizations.
- Establish process engineering execution strategies and technical standards; ensure alignment with manufacturing needs, regulatory expectations, and corporate standards.
- Drive cross-functional integration (engineering, operations, quality, PDS&T).
- Act as Process Engineering Design Authority; govern/approve key deliverables (PFDs, P&IDs, cause & effect, schematics/system architecture, control narratives, operations philosophy).
- Lead multidisciplinary design reviews for completeness, operability, and compliance.
- Ensure design consistency across process, mechanical, utilities, automation, and facility systems.
- Support stage-gate governance; ensure deliverables reach required maturity each phase.
- Define/oversee process system architecture, boundaries, equipment integration; integrate with utilities, automation/control, infrastructure, cleanroom/environmental systems.
- Oversee process fluid/line list development; stream classification; assess compatibility, corrosion, and contamination risks.
- Provide piping governance (pipe sizing/hydraulics, pressure drop/flow analysis, line classification/specs) supporting reliability, cleanability, maintainability, and sterility (as applicable).
- Ensure process safety management (PSM) compliance; oversee relief sizing, overpressure protection, PHA/HAZOP facilitation and resolution; review safety-critical analyses.
- Lead development/approval of operations philosophy; support safe startup/shutdown/maintenance/cleaning.
- Integrate human factors (accessibility/maintainability); collaborate with operations and MSAT.
- Support CQV systemization/turnover; provide technical support during startup/readiness.
- Lead resolution of process engineering issues during commissioning/qualification.
- Monitor contractor performance, deliverable quality, and resource utilization; oversee budgets/resource plans; support cost estimates/schedules; identify/mitigate project risks.
- Contribute to/lead high-performing project organization; foster safety, accountability, collaboration, and operational excellence.
Qualifications:
- BS in Engineering (or equivalent); Master’s in Engineering or MBA preferred.
- 20+ years as Senior Engineering/Projects/Operations leader across multiple technologies.
- Proven leadership in mega-capital projects ($500MM–$1B+).
- Deep knowledge of biopharmaceutical engineering systems across disciplines.
- Inclusive leadership of large cross-functional teams; ability to communicate with senior leadership/executives.
- Experience managing engineering contractors and global equipment vendors.
- Results-oriented leadership; strong negotiation and risk-based decision-making.
- Ability to mentor/develop next-generation leaders.
- Travel within the US (and outside the US) for reviews/workshops/vendor visits.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees).
- Eligible to participate in short-term incentive programs.
- Lead process engineering for multiple strategic biopharmaceutical capital projects; act as owner-side Design Authority and provide technical governance/oversight of process engineering activities for large-scale manufacturing facility projects.
Responsibilities:
- Lead a team of SME to drive A&E consultant engineering schedules.
- Ensure process engineering deliverables are reviewed, approved, and issued for design/construction to avoid project interruption.
- Serve as owner’s senior process engineering leader; provide leadership and coordinate with contractor engineering organizations.
- Establish process engineering execution strategies and technical standards; ensure alignment with manufacturing needs, regulatory expectations, and corporate standards.
- Drive cross-functional integration (engineering, operations, quality, PDS&T).
- Act as Process Engineering Design Authority; govern/approve key deliverables (PFDs, P&IDs, cause & effect, schematics/system architecture, control narratives, operations philosophy).
- Lead multidisciplinary design reviews for completeness, operability, and compliance.
- Ensure design consistency across process, mechanical, utilities, automation, and facility systems.
- Support stage-gate governance; ensure deliverables reach required maturity each phase.
- Define/oversee process system architecture, boundaries, equipment integration; integrate with utilities, automation/control, infrastructure, cleanroom/environmental systems.
- Oversee process fluid/line list development; stream classification; assess compatibility, corrosion, and contamination risks.
- Provide piping governance (pipe sizing/hydraulics, pressure drop/flow analysis, line classification/specs) supporting reliability, cleanability, maintainability, and sterility (as applicable).
- Ensure process safety management (PSM) compliance; oversee relief sizing, overpressure protection, PHA/HAZOP facilitation and resolution; review safety-critical analyses.
- Lead development/approval of operations philosophy; support safe startup/shutdown/maintenance/cleaning.
- Integrate human factors (accessibility/maintainability); collaborate with operations and MSAT.
- Support CQV systemization/turnover; provide technical support during startup/readiness.
- Lead resolution of process engineering issues during commissioning/qualification.
- Monitor contractor performance, deliverable quality, and resource utilization; oversee budgets/resource plans; support cost estimates/schedules; identify/mitigate project risks.
- Contribute to/lead high-performing project organization; foster safety, accountability, collaboration, and operational excellence.
Qualifications:
- BS in Engineering (or equivalent); Master’s in Engineering or MBA preferred.
- 20+ years as Senior Engineering/Projects/Operations leader across multiple technologies.
- Proven leadership in mega-capital projects ($500MM–$1B+).
- Deep knowledge of biopharmaceutical engineering systems across disciplines.
- Inclusive leadership of large cross-functional teams; ability to communicate with senior leadership/executives.
- Experience managing engineering contractors and global equipment vendors.
- Results-oriented leadership; strong negotiation and risk-based decision-making.
- Ability to mentor/develop next-generation leaders.
- Travel within the US (and outside the US) for reviews/workshops/vendor visits.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees).
- Eligible to participate in short-term incentive programs.