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.
Your Role:
The Sr. Director of Engineering is accountable for the 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.
Key Responsibilities:
Engineering Strategy & Governance
- 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.
Key Engineering Metrics & Reporting
- Capital project performance: safety, schedule, cost, and quality
- Engineering technical risk profile and mitigation effectiveness
- Asset reliability, availability, and utility system performance
- Change management and deviation trends
- Inspection readiness and compliance health
- Engineering standardization, reuse, and productivity metrics
Minimum Qualifications:
- Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or related discipline).
- 15+ years of experience in pharmaceutical or biotechnology engineering and capital project delivery.
- Proven leadership of large engineering organizations and complex capital programs.
- Deep expertise in GMP facility, utility, and manufacturing system design.
- Experience operating in owner-side, EPCM, or integrated project delivery environments.
- Strong executive communication, judgment, and stakeholder management skills.
Position Type/Expected Hours of Work:
This role is a full-time onsite position in our Tustin or Irvine, CA location. Days and hours of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $203,200 - $254,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
