Design and Technology Lead

- Oversee and ensure adherence to engineering design standards across all CapEx projects - Develop and maintain a knowledge management system for design content accessibility and understanding - Lead both conceptual and detailed design phases for significant capital projects, adhering to cGMP, FDA, EMA, and international standards - Validate project design deliverables against defined scope, budget, and timelines - Formulate initial project scope, design basis, and feasibility analyses - Collaborate with stakeholders to establish project requirements and design parameters - Conduct design assurance evaluations and checks at critical project milestones - Identify potential risks and implement strategies to uphold design integrity - Offer expertise to site engineering teams about design standards and best practices - Mentor site engineers and facilitate knowledge sharing across global teams - Partner with external design experts and EPC companies to ensure quality and compliance - Negotiate contracts related to design and manage vendor performance - Incorporate digital design technologies and BIM methodologies for enhanced efficiency - Champion sustainability and modular design approaches in capital projects - Act as the go-to expert for aseptic processing technologies, ensuring top-tier practices in project scope and system management - Spearhead the development and application of aseptic manufacturing process technology strategies, including equipment selection and process integration - Define and oversee process technology requirements during project planning to align with regulatory and business objectives - Supervise the specification, design, and qualification of aseptic processing systems and machinery - Provide expert guidance and support for technology transfer, scale-up, and commissioning of aseptic processes - Maintain lifecycle documentation as the system owner for aseptic process technologies to ensure ongoing compliance - Assist manufacturing operations in troubleshooting issues related to aseptic equipment and processes - Collaborate with manufacturing, quality, and engineering teams to drive continuous improvements in aseptic operations - Ensure comprehensive training and knowledge transfer regarding aseptic process technologies at global sites - Stay abreast of industry trends and regulatory updates, adapting process technology strategies as required to maintain a competitive edge and compliance