IM PD ATMP Technical Lead

Role Summary

Innovative Medicine Project Delivery ATMP Technical Lead responsible for providing expert engineering leadership and guidance across facility design, construction, commissioning, and process validation for Advanced Therapies & Medicinal Products facilities. Drives a vision and standards for standard Facility and Equipment design and ensures seamless handover from project to operations.

Responsibilities

• Keep abreast of current industry and regulatory standards and trends to ensure ATMP 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 safe, compliant transitions from project to start-up.
• Develop new engineering standards for facility design for Advanced Therapies & Medicinal Products.
• Provide expert engineering 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 align technology standards and project execution.
• 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.

Qualifications

• A 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 and Advanced Therapies 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 balance multiple priorities and communicate effectively in a high-profile environment.
• Fluent in written and spoken English.
• Requires at least 25% domestic and international travel.
• Hybrid remote and in-office work location.

Skills

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