IM PD ATMP Technical Lead

Role Summary

Innovative Medicine Project Delivery ATMP Technical Lead to join the Engineering & Property Services team, providing end-to-end technical leadership in facility design, construction, commissioning and process validation for Advanced Therapies & Medicinal Products facilities across multiple locations.

Responsibilities

• Keep abreast of current industry and regulatory standards and trends to ensure ATMP facilities are designed, built and commissioned to leading edge standards.
• Define and deploy a vision and strategy for standard Facility and Equipment design for IM ATMP capital projects.
• Oversee design and creation of Facility and Equipment processes and standards for safe, compliant transitions from project build to start-up.
• Develop new engineering standards for facility design for Advanced Therapies & Medicinal Products.
• Provide expert engineering technical support in facility need, design, construction, commissioning and process validation for green field and brown field facilities.
• Nurture future talent by mentoring internal and external engineers.
• Collaborate with the ATMP global engineering team head to align with technology standards and specifications for manufacturing technology.
• Ensure compliance with policies, procedures, regulations and customer specifications.
• Proactively research and implement new standards to drive growth and efficiency.
• Report to senior management regularly on activities and status.

Interfaces

• J&J Engineering & Property Services (E&PS).
• E&PS Project leadership (design, construction and commissioning).
• J&J Quality Assurance.
• J&J Advanced Therapies and Medicinal Products global engineering.

Requirements

• Strong technical background with excellent communication skills; proven track record in engineering excellence and standards development.
• Expert knowledge in: Plasmid Manufacturing; Viral Manufacturing (Cells Expansion, Transfection, Clarification, Purification, Aseptic Filling, Cold Storage, Thawing); Cell Processing (Cryo-Preservation, Thawing, Isolate & Enrich, Activate & Modify, Expansion, Harvest, Final Formulation, Final Aseptic Filling); Packaging & Inspection; Finish Product Cryo-Preservation; Single Use Components; Cleaning and Sterilization processes; Waste Handling; Gowning; Materials, People & Waste Flows.
• Bachelor's degree in engineering required; Master’s/MBA/PhD preferred.
• Minimum 12 years of manufacturing, project engineering, supply chain and capital project execution in Pharma/ATMP industries.
• Hands-on experience designing, constructing, commissioning or qualifying manufacturing process equipment.
• Large capital project management experience over $200 million.
• Ability to balance multiple priorities and operate with poise in a high-profile environment.
• Fluent in English (written and spoken).
• Travel: minimum 25% domestic and international.
• Hybrid remote and in-office primary work location.

Education

• Bachelor's degree in engineering required; advanced degree preferred.

Skills

• Agile Decision Making, Budget Management, Business Planning, Collaboration, Customer Centricity, Developing Others, Leadership, Lean Supply Chain Management, Project Engineering, Project Integration Management, Quality Assurance, Regulatory Compliance, STEM application, Scientific Research, Stakeholder Engagement