Associate Director, Engineering and Facilities

Responsibilities

Engineering 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