The Associate Director, Engineering and Facilities is accountable for the strategic leadership, reliability, and compliance of all facility, utility, and engineering systems supporting cGMP bioconjugation manufacturing operations. This role ensures uninterrupted execution of manufacturing through robust facility performance, lifecycle asset management, and engineering excellence.
This position owns site infrastructure, including GMP utilities, cleanroom environments, process equipment, and building systems. The Associate Director establishes and drives a reliability-centered maintenance program, capital project execution, and long-term infrastructure strategy to support clinical and commercial manufacturing.
The role operates as a core member of the site leadership team and is directly responsible for eliminating facility-related execution risk, ensuring inspection readiness, and enabling right-first-time manufacturing performance.
ResponsibilitiesEngineering Leadership - Lead Engineering teams, including maintenance, calibration, metrology, and facilities operations
- Build a culture of accountability, technical ownership, and urgency aligned with manufacturing needs
- Establish clear roles, expectations, and performance management across the organization
GMP Compliance and Inspection Readiness - Ensure facilities and engineering systems operate in full compliance with cGMP, FDA, EMA, and global regulatory expectations, own deviation investigations, CAPAs, change controls, and engineering-related quality systems
- Lead facility and utility support during internal, client, and regulatory inspections
- Ensure all systems are maintained in a validated state, including qualification and requalification activities
Bioconjugation Process Support - Ensure facility and equipment design supports safe handling of high-potency compounds and complex conjugation processes
- Support containment strategies, environmental controls, and cleaning systems specific to ADC and bioconjugation manufacturing
- Partner with MSAT and Manufacturing to troubleshoot process-related equipment issues and optimize performance
- Ensure alignment between process requirements and facility capabilities
Financial and Resource Management - Develop and manage Engineering budgets, including maintenance, capital, and contracts
- Optimize resource allocation to balance cost, risk, and operational performance
- Build workforce plans aligned with site growth and operational complexity
Continuous Improvement and Strategy - Establish KPIs and Tier escalation for Engineering performance
- Drive continuous improvement initiatives focused on reliability, efficiency, and compliance
- Implement industry best practices in maintenance, asset management, and digital systems
- Develop long-term infrastructure strategy to support commercial readiness and scale
Qualifications- 5+ years of experience in pharmaceutical or biotechnology manufacturing, with significant experience in engineering and facilities leadership
- Proven experience supporting cGMP operations, including biologics or bioconjugation manufacturing environments
- Demonstrated leadership of engineering, maintenance, and facilities teams in a regulated environment
- Deep understanding of GMP utilities, cleanroom design, and facility operations
- Strong experience with capital project execution, including equipment and facility commissioning and qualification
- Expertise in CMMS systems, asset lifecycle management, and reliability engineering principles
- Strong knowledge of regulatory expectations (FDA, EMA) related to facilities and engineering systems
- Ability to operate at both strategic and tactical levels, driving execution while setting long-term direction
- Strong problem-solving capability with a focus on root cause and sustainable solutions
- Effective communicator with the ability to influence cross-functional teams and senior leadership
FLSA: Exempt
