Senior Director, Engineering

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 so procurement and construction proceed without interruption.
- Provide strategic leadership and oversight for engineering execution across large-scale pharmaceutical/biopharmaceutical capital projects (manufacturing facilities, laboratories, cleanrooms, supporting utilities).
- Lead multidisciplinary engineering teams and manage global engineering partners to deliver high-quality, GMP-compliant facility and process designs meeting safety, quality, cost, and schedule objectives.
- Integrate engineering activities across project phases (concept through design, construction, commissioning, qualification, and operational readiness) under the company’s governance and stage-gate framework.
- Establish engineering execution strategies aligned with corporate standards and global best practices; ensure consistency across projects and sites.
- Ensure designs support long-term operability, maintainability, and lifecycle performance.
- Drive timely delivery of engineering design packages aligned to project schedules.
- Drive procurement including technical bid analysis/evaluation and testing of vendor packages (FAT, SAT).
- Provide technical leadership for complex design decisions and cross-functional engineering issues.
- Ensure contractors deliver engineering work consistent with company standards, quality expectations, and regulatory requirements; monitor performance, deliverable quality, and resource utilization.
- Oversee engineering budgets and resource plans; support capital cost estimates and engineering schedules.
- Identify and mitigate risks impacting cost or timeline.
- Establish and maintain project governance, reporting structures, and decision-making frameworks for stakeholder alignment.
- Lead integrated project teams across engineering, construction, CQV, quality, and manufacturing.
- Ensure facility design alignment with long-term manufacturing network strategy and product pipeline requirements.
- Oversee aseptic processing facility design (cleanroom classifications, contamination control, filling systems, lyophilization, sterile formulation).
- Ensure design supports qualification, regulatory approval, and operational excellence from day one.
- Manage capital expenditure including cost forecasting, change management, and financial reporting.
- Establish risk-based CQV strategy leveraging digital technologies to accelerate facility/equipment qualification.
- Identify and mitigate technical, regulatory, schedule, and supply chain risks; develop what-if scenarios.
- Build and lead a high-performing project organization; foster a culture of safety, accountability, collaboration, and operational excellence.

Qualifications:
- BS in Engineering (or equivalent technical degree); Master’s degree in Engineering preferred.
- 20+ years’ experience as a Senior Engineering/Projects/Operations leader across multiple technologies.
- Proven leadership in engineering biopharmaceutical mega-capital projects ($500MM–$1B+).
- Deep knowledge of engineering systems and cGMP requirements in a biopharmaceutical facility.
- Proven inclusive leadership managing large cross-functional teams and communicating with senior leadership/external authorities.
- Demonstrated experience managing engineering contractors and global equipment vendors.
- Results-oriented leadership with strong negotiation skills and risk-based decision-making.
- Ability to mentor and develop next-generation leaders.
- Required travel for reviews/workshops/visits to vendor facilities (within the US and outside the US).