IM PD Bio-Therapeutics Technical Lead

Role Summary

Innovative Medicine Project Delivery ATMP Technical Lead responsible for providing expert engineering technical support and guidance in facility design, construction, commissioning, and process validation for Drug Substance and Drug Product facilities. Lead a vision and strategy for standard Facility and Equipment design across IM capital projects, ensuring safe, compliant, and reliable handover from project to operations.

Responsibilities

• Keep abreast of current industry and regulatory standards and trends to ensure facilities are designed, built and commissioned to leading edge standards.
• Define and deploy a vision and strategy for a standard Facility and Equipment design for IM Bio-Therapeutics capital projects.
• Oversee design and creation of Facility and Equipment processes and standards to enable safe transitions from project build to start-up.
• Develop new engineering standards for Bio-Therapeutics facility design.
• Provide expert engineering technical support across design, construction, commissioning and process validation for Drug Substance and Drug Product facilities (green and brown field).
• Nurture and mentor internal and external engineers.
• Collaborate with the Global Engineering Technology team to align with technology standards and project execution.
• Ensure compliance with policies, regulations, and customer specifications.
• Research and implement new standards to drive growth and efficiency.
• Report to senior management on activities and status.

Interfaces

• J&J Engineering & Property Services (E&PS).
• E&PS Project leadership (Project Director, E&PS Director).
• J&J Quality Assurance.
• J&J Global Engineering and Technology (GET).

Qualifications

• Education: Bachelor's in engineering required; Master's/MBA/PhD preferred.
• Required: Minimum 15 years in manufacturing, project engineering, supply chain and capital project execution in the Bio-Pharmaceutical industry; hands-on experience designing, constructing, commissioning or qualifying manufacturing process equipment; deep expertise in Bio-Pharmaceutical Drug Substance and Drug Product processes including Annex 1; large capital project management over $250 million; ability to manage multiple priorities and communicate effectively; fluent in English; travel at least 25% (domestic/international); hybrid remote/in-office work location.
• Preferred: Strong leadership and collaboration skills, experience with regulatory compliance, and ability to mentor teams.