Sr. Director of Engineering

Key Responsibilities

• Define and maintain the overall engineering strategy, standards, and governance model for pharmaceutical manufacturing.
• Establish and enforce global and site-level engineering standards, specifications, and design guides.
• Serve as final technical authority for major design, technology, and execution decisions.
• Ensure alignment between business strategy, manufacturing demand, and engineering investments.
• Drive consistency, scalability, and reuse across sites, platforms, and capital programs.

Capital Project Leadership & Oversight

• Provide executive engineering oversight for capital projects across all phases: concept, FEED, detailed design, construction, CQV, and handover.
• Ensure technical scope, design intent, and GMP requirements are clearly defined, communicated, and controlled.
• Sponsor and chair design reviews, constructability reviews, technical risk reviews, and readiness assessments.
• Support value engineering and cost optimization while preserving compliance, safety, and long-term operability.
• Partner with Project Management, Project Controls, and Finance to align technical scope, schedule, and budget.

GMP Compliance & Regulatory Alignment

• Ensure all engineering activities comply with FDA, EU GMP, Annex 1, and applicable global regulatory requirements.
• Partner with Quality to embed data integrity, contamination control, and aseptic design principles into facilities and systems.
• Support regulatory submissions, inspections, audits, and responses related to facilities and engineering systems.
• Ensure inspection-ready facilities through robust documentation, traceability, and engineering change control.
• Serve as senior engineering representative during regulatory interactions and inspections.

Facilities, Utilities & Asset Lifecycle Management

• Oversee the design, delivery, and lifecycle management of manufacturing facilities and critical utilities.
• Provide governance for HVAC, cleanrooms, WFI, clean steam, process gases, electrical systems, and automation infrastructure.
• Establish asset lifecycle, reliability, and capacity strategies aligned with operational needs.
• Ensure maintainability, operability, and safety considerations are addressed early in design.
• Govern transition from capital project execution into routine plant operations and technical operations organizations.

Organization Leadership & Talent Development

• Lead, develop, and mentor multi-disciplinary engineering organizations across sites or programs.
• Define engineering organizational structures, roles, responsibilities, and operating models.
• Build internal engineering capability and determine make-versus-buy strategies.
• Establish competency frameworks, training strategies, performance expectations, and succession planning.
• Foster a strong culture of safety, quality, accountability, and continuous improvement.

Cross-Functional Collaboration

• Serve as a senior technical partner to Operations, Quality, EHS, Finance, Procurement, MSAT and IT/OT.
• Support manufacturing strategy, capacity expansion, tech transfers, and new product introductions.
• Partner with Procurement on EPC and EPCM strategy, vendor selection, and technical evaluations.
• Ensure engineering solutions support operational excellence, reliability, and business continuity.

Risk, Safety & Technical Assurance

• Own technical risk management across engineering, capital projects, and operational systems.
• Ensure robust safety-in-design practices including HAZOP, PHA, biosafety, and constructability reviews.
• Oversee engineering change control, deviations, investigations, and technical decision documentation.
• Ensure EHS, process safety, and biosafety principles are embedded throughout the asset lifecycle.

Technology, Digitalization & Sustainability

• Drive adoption of new manufacturing, facility, and utility technologies.
• Champion digital engineering tools, data-driven decision making, and smart factory initiatives.
• Support sustainability, energy efficiency, and decarbonization programs.
• Evaluate emerging technologies for technical readiness and strategic value.