Sr. Manager Engineering

Role Overview:

The Senior Manager, Engineering, is responsible for leading a multidisciplinary engineering organization supporting commercial CARVYKTI® cell therapy manufacturing operations. This role provides strategic and technical leadership for the lifecycle management of manufacturing equipment and systems, process optimization initiatives, manufacturing troubleshooting, cost of goods reduction programs, and management of a Facilities Investigation Team responsible for non-conformance investigations.

The successful candidate will lead a team of engineers and investigators that ensure manufacturing equipment reliability, operational excellence, regulatory compliance, and continuous improvement across the cell therapy manufacturing process. This position serves as a key partner to Manufacturing, Quality, Validation, Maintenance, MSAT, Supply Chain, and Regulatory functions to ensure uninterrupted production and continuous advancement of manufacturing capabilities.

Key Responsibilities:

• Lead, develop, and mentor a team of engineering professionals responsible for cell therapy manufacturing operations and equipment support.
• Establish team goals, performance objectives, and development plans aligned with site and business priorities.
• Foster a culture of safety, accountability, technical excellence, innovation, and continuous improvement.
• Build organizational capabilities to support commercial growth, technology transfer activities, and future manufacturing expansion.
• Own lifecycle management strategies for cell therapy manufacturing equipment, utilities, and process systems.
• Ensure equipment reliability, availability, and compliance throughout the asset lifecycle.
• Oversee equipment qualification, change management, obsolescence planning, capacity planning, and technology upgrades.
• Partner with Validation, Maintenance, and Quality organizations to maintain equipment in a validated state and inspection readiness.
• Provide engineering leadership for troubleshooting complex manufacturing equipment and process performance issues.
• Lead root cause analysis efforts for equipment-related deviations, process interruptions, and manufacturing challenges.
• Identify and implement process optimization opportunities to improve equipment utilization, throughput, yield, reliability, and operational efficiency.
• Utilize data analytics and performance metrics to drive evidence-based decision making.
• Support new technologies, automation solutions, digital manufacturing initiatives, product introductions, process changes, technology transfers, and facility expansion.
• Develop and execute engineering strategies to reduce manufacturing costs while maintaining product quality, compliance, and patient supply.
• Lead continuous improvement initiatives focused on process efficiency, cycle time reduction, yield improvement, labor optimization, and waste reduction.
• Identify and execute capital and operational efficiency projects with measurable business impact.
• Lead the Facilities Investigation Team supporting manufacturing non-conformance, deviation, and investigation activities.
• Ensure thorough, scientifically sound investigations and effective corrective and preventive action programs.
• Partner with Manufacturing, Quality, MSAT, and Regulatory teams to assess product and process impact of manufacturing events.
• Ensure investigation quality, compliance, and closure timelines meet site and regulatory requirements.
• Ensure engineering activities comply with cGMP, FDA, EMA, and applicable global regulatory requirements.
• Support internal audits, regulatory inspections, quality system initiatives, risk assessments, change control reviews, and quality management processes.
• Serve as a key technical leader and provide recommendations and presentations to site leadership and senior management.

Requirements:

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Electrical, or related discipline) required.
• Master's degree or MBA preferred.
• 10+ years of engineering, manufacturing, technical operations, or process support experience within the pharmaceutical, biotechnology, biologics, cell therapy, or related regulated industry.
• 5+ years of people leadership experience managing technical or engineering teams.
• Experience supporting cGMP manufacturing operations required.
• Experience leading complex investigations, root cause analysis, and CAPA implementation preferred.
• Experience supporting commercial biologics, advanced therapies, or cell therapy manufacturing highly preferred.
• Demonstrated success leading continuous improvement and cost reduction initiatives.
• Experience with equipment lifecycle management and asset reliability programs.
• Knowledge of cell therapy, biologics, or aseptic manufacturing processes.
• Knowledge of deviation management, non-conformance investigations, and quality systems.
• Knowledge of root cause analysis methodologies, including Fishbone, 5 Why, and Fault Tree Analysis.
• Knowledge of process optimization and operational excellence methodologies.
• Knowledge of change control, validation, and risk management principles.
• Knowledge of regulatory requirements including FDA, EMA, ICH, and cGMP standards.

Compensation and Benefits:

The base pay range is $146,410–$192,164 USD. Actual compensation may vary based on experience, skills, qualifications, and geographic location. Performance-based bonus and/or equity may be available to eligible employees.

Benefits include medical, dental, and vision insurance, a 401(k) retirement plan with company match, paid parental leave, paid time off, company holidays, flexible spending and health savings accounts, life and disability insurance, legal assistance, supplemental insurance plans, commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.