IM PD ATMP Technical Lead

Role Summary

Innovative Medicine Project Delivery ATMP Technical Lead. Lead and provide technical guidance for facility design, construction, commissioning and process validation of Advanced Therapies & Medicinal Products facilities across multiple sites and countries.

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 a standard Facility and Equipment design for IM ATMP capital projects.
• Oversee the design and creation of Facility and Equipment processes and standards to ensure safe, compliant, and reliable transitions from project to start-up.
• Develop new engineering standards for facility design for Advanced Therapies & Medicinal Products.
• Provide expert engineering technical support in facility business 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 ensure alignment with technology standards and manufacturing technology specifications.
• Ensure compliance with policies, procedures, government regulations, and customer specifications.
• Proactively research and implement new standards to drive growth and efficiency.
• Report regularly to senior management on activities and status.

Qualifications

• Bachelor's in engineering required; Master's/MBA/PhD preferred.
• Minimum 12 years of manufacturing, project engineering, supply chain and capital project execution in Pharma and ATMP industries.
• Hands-on experience designing, constructing, commissioning or qualifying manufacturing process equipment.
• Strong ATMP process engineering expertise.
• Large capital project management experience over $200 million.
• Ability to manage multiple priorities and communicate effectively in a high-profile environment.
• Fluent in English (written and spoken).
• Minimum 25% domestic and international travel.
• Hybrid remote and in-office work location.

Skills

• Agile Decision Making
• Budget Management
• Leadership and Team Development
• Regulatory Compliance
• Project Engineering and Integration
• Quality Assurance (QA)
• STEM Application
• Stakeholder Engagement

Education

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