IM PD ATMP Technical Lead

Role Summary

Innovative Medicine Project Delivery ATMP Technical Lead, located across multiple sites (New Brunswick, Raritan, Titusville, Malvern, Horsham in the US; Beerse in Belgium; Leiden in the Netherlands). Provides end-to-end technical leadership in facility design, construction, commissioning and process validation for Advanced Therapies & Medicinal Products facilities, guiding standardization of Facility and Equipment design for IM ATMP capital projects.

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 to ensure safe, compliant, and reliable 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 business need, design, construction, commissioning and process validation for greenfield and brownfield ATMP 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 with manufacturing technology specifications.
• Ensure compliance with policies, procedures, government regulations, and customer specifications.
• Proactively research and implement new standards to drive business growth and efficiency.
• Report regularly to senior management on activities and status.

Qualifications

• 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 Pharmaceutical 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 balance multiple priorities and operate with poise in a high-profile environment.
• Fluent in written and spoken English.
• Minimum 25% domestic and international travel.
• Hybrid remote and in-office work location.

Skills

• Agile Decision Making
• Budget Management
• Project Engineering
• Project Integration Management
• Regulatory Compliance
• Quality Assurance
• Leadership and Developing Others
• Stakeholder Engagement

Education

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

Additional Requirements

• Travel up to 25% domestically and internationally.