IM PD ATMP Technical Lead

Role Summary

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

Responsibilities

• Keep abreast of current industry and regulatory standards and trends to ensure ATMP manufacturing plants 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 the design and creation of Facility and Equipment processes and standards to ensure a safe, compliant transition 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 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 technology standards and project execution.
• Ensure compliance with policies, procedures, 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 (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 leading-edge standards.
• Expert knowledge areas include: 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/ Sterilization/ Validation Processes; Waste Handling; Gowning; Materials, People & Waste Flows.
• Bachelor's degree in engineering required; Master's/MBA/PhD preferred.
• Minimum 12 years in manufacturing, project engineering, supply chain and capital project execution in Pharmaceutical/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 communicate with poise in a high-profile environment.
• Fluent in English (written and spoken).
• Up to 25% domestic and international travel.
• Hybrid remote and in-office work location.

Skills

• Agile Decision Making, Budget Management, Business Planning, Collaboration, Customer Centricity, Developing Others, Financial Competence, Inclusive Leadership, Leadership, Lean Supply Chain Management, Organizational Project Management, Project Engineering, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, STEM Applications, Scientific Research, Stakeholder Engagement