Sr Manager/Associate Director, Engineering

Abzena Inc.•Bristol, PA

21h

About The Position

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. 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.

Requirements

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

Responsibilities

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
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
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
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
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