Sr. Director of Engineering

Description

Looking to join a passionate team dedicated to developing and manufacturing life‑saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

The Sr. Director of Engineering is accountable for strategic leadership, governance, and execution of engineering across operations and capital programs. This role serves as the senior technical authority for facilities, utilities, process engineering, automation, and project engineering, ensuring assets are designed, delivered, and operated in compliance with global GMP, safety, quality, and business requirements. The role spans the full asset lifecycle from portfolio planning and concept development through design, execution, CQV, handover, and sustained operational performance.

• 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.

• 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.

• 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.

• Oversee the design, delivery, and lifecycle management of manufacturing facilities and critical utilities.
• Provide governance for HVAC, clean rooms, 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.

• 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.

• 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.