Monoclonal Antibody Area Lead (Biologics)

Location: Richmond, Virginia, United States

Company

hirify.global Sustainable Technology Solutions provides process technologies, advisory services, technical expertise, energy transition solutions, engineering design, and smart solutions across the asset life cycle.

What you will do

• Lead the technical delivery of an assigned facility area supporting commercial monoclonal antibody manufacturing.
• Ensure engineering designs, equipment selections, construction activities, CQV execution, and operational readiness meet manufacturing, quality, compliance, cost, schedule, and operational objectives.
• Coordinate Lilly stakeholders, the PMC organization, EPCM and construction contractors, CQV teams, and equipment suppliers.
• Lead technical decision-making, risk management, issue resolution, stakeholder alignment, and readiness planning.
• Integrate design, construction, qualification, startup, and operational handover activities while supporting cross-functional collaboration and performance monitoring.

Requirements

• Bachelor’s degree in Pharmaceutical Engineering or a related technical discipline.
• At least 15 years of engineering experience supporting pharmaceutical, biotechnology, or other GMP-regulated facilities, including at least 10 years in biologics and monoclonal antibody facilities.
• Experience managing large multidisciplinary engineering teams and engineering contractors.
• Demonstrated ability to lead technical decision-making and stakeholder alignment.
• Strong leadership and stakeholder management capabilities.

Nice to have

• Experience as an Owner’s Representative or in a PMC role for major capital projects exceeding $1B TIC.
• Professional Engineer license and/or PMP certification.
• Experience supporting commissioning, startup, and operational readiness activities.

Culture & Benefits

• Benefits may include a 401(k) plan with company match, medical, dental, vision, life insurance, AD&D, flexible spending account, disability coverage, and paid time off.
• Flexible work schedule options may be available.
• Professional training and development support career advancement.
• People First and Zero Harm principles guide the work environment.