Design and Technology Lead

Salary: $167000 - 222000 per year Requirements: Bachelors or Masters degree in Engineering (Mechanical, Electrical, Chemical, Civil, or related field) 12+ years of experience in engineering design and process technology for GMP-regulated facilities, with a minimum of 8 years in leadership roles Established history of managing Tier 1 capital project design, assurance, and aseptic process technology PMP certification or equivalent; LEED or sustainability certification is a plus Strong expertise in biopharma facility design, aseptic processing, clean utilities, HVAC, and process systems Familiarity with ISPE Baseline Guides, ASTM E2500, and risk-based design methodologies Experience with biologics, cell & gene therapy, or sterile manufacturing environments Proficient in BIM, AutoCAD, and digital design tools Global perspective and proficiency in navigating a matrix organization Responsibilities: 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 Technologies: BIM Support Matrix Architect Flow More: At Cobalt Streamworks, we are a worldwide leader in biotherapeutics, dedicated to our mission of saving lives. Our focus is on meeting patient needs by leveraging cutting-edge technologies to discover, develop, and deliver innovative therapies for conditions across various therapeutic areas, including immunology and hematology. We utilize our core scientific platforms in plasma fractionation, recombinant protein technology, and cell and gene therapy to consistently innovate and address unmet medical needs. With one of the largest plasma collection networks globally, we are committed to improving patient outcomes. We offer a collaborative and inclusive environment that values diversity, fosters teamwork, and encourages professional growth, while operating in over 100 countries. We also prioritize employee well-being through comprehensive benefits and support structures, allowing our team to thrive both personally and professionally. last updated 28 week of 2026