About this role
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.
Responsibilities
Capital Project Management
- Lead all site CAPEX projects from concept through commissioning and operational handoff.
- Develop project scopes, budgets, timelines, and resource plans.
- Manage installation of new manufacturing equipment, laboratory instruments, utilities, and facility systems.
- Coordinate architectural, engineering, and construction activities.
- Oversee contractor selection, vendor management, and contract administration.
- Track project expenditures and ensure adherence to approved budgets.
Facility Infrastructure
- Manage facility upgrades involving HVAC, compressed air, purified water, electrical, process utilities, and building systems.
- Support facility expansions, renovations, and optimization initiatives.
- Ensure infrastructure supports current and future business growth requirements.
Regulatory & Compliance
- Ensure projects comply with GMP, FDA, OSHA, EPA, and local building code requirements.
- Partner with Validation and Quality teams on qualification and commissioning activities.
- Support audits and inspections related to facilities and engineering projects.
Strategic Planning
- Develop and maintain a multi-year capital improvement roadmap.
- Identify opportunities for operational efficiencies, sustainability, and cost savings.
- Support long-range facility planning and capacity expansion initiatives.
Leadership & Team Management
- Lead, coach, and develop Facilities Engineers, Project Managers, and Project Coordinators.
- Conduct performance reviews and development planning.
- Establish project priorities and workload management across the team.
- Foster a culture of safety, accountability, and continuous improvement.
Qualifications
- Bachelor's degree in Engineering, Facilities Management, Construction Management, or related field required.
- 7+ years of facilities, engineering, or capital project management experience.
- 3+ years of people leadership experience.
- Experience managing projects in GMP-regulated manufacturing environments.
- Demonstrated success leading capital projects Experience supporting pharmaceutical, biotech, diagnostics, or medical device manufacturing facilities.
- Knowledge of commissioning, qualification, and validation processes.