Design & Technology Lead

The Technology & Design Lead is responsible for design ownership and governance across Tier 1 capital projects ($50M+), ensuring alignment with business objectives, regulatory requirements, and industry best practices. The role provides process technology leadership with a focus on aseptic processing, ensuring robust process definition, system ownership, and ongoing manufacturing support for aseptic equipment operations, fostering consistency and innovation in design and technology execution globally.

• Establish and maintain appropriate engineering design standards to ensure consistency across all CapEx projects.
• Develop and manage a knowledge management program to ensure all design content is available and understood globally and at site levels.
• Lead conceptual and detailed design phases for Tier 1 capital projects, ensuring compliance with cGMP, FDA, EMA, and global standards.
• Validate design deliverables against project scope, budget, and schedule.
• Develop initial project scope, basis of design, and feasibility assessments.
• Collaborate with stakeholders to define user requirements and design criteria.
• Execute design assurance reviews and health checks at key project milestones.
• Identify risks and implement corrective actions to maintain design integrity.
• Provide expert advice to site engineering teams on design standards and best practices.
• Mentor site engineers and promote knowledge sharing across global teams.
• Engage with external design partners and EPC firms to ensure quality and compliance.
• Negotiate design-related contracts and manage vendor performance.
• Implement digital design tools and BIM methodologies for efficiency.
• Drive sustainability and modular design strategies in capital projects.
• Serve as the global subject matter expert for aseptic processing technologies, ensuring best-in-class practices in project definition and system ownership.
• Lead the development and implementation of process technology strategies for aseptic manufacturing, including equipment selection, process flow, and integration with facility design.
• Define and own process technology requirements during project scoping, ensuring alignment with regulatory and business needs.
• Oversee the specification, design, and qualification of aseptic processing systems and equipment.
• Provide technical leadership and support for technology transfer, scale-up, and commissioning of aseptic processes.
• Act as system owner for aseptic process technologies, maintaining lifecycle documentation and ensuring ongoing compliance.
• Support manufacturing operations by troubleshooting and resolving complex issues related to aseptic equipment and processes.
• Collaborate with manufacturing, quality, and engineering teams to drive continuous improvement in aseptic operations.
• Ensure robust training and knowledge transfer for aseptic process technologies across global sites.
• Monitor industry trends and regulatory changes, adapting process technology strategies as needed to maintain competitive advantage and compliance.