Design & Technology Lead

CSL

About The Position

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. Provide process technology leadership with a focus on aseptic processing. The position ensures robust process definition, system ownership, and ongoing manufacturing support for aseptic equipment operations, fostering consistency and innovation in design and technology execution globally.

Requirements

Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Chemical, Civil, or related discipline).
12+ years in engineering design and process technology for GMP-regulated facilities, with at least 8 years in leadership roles.
Proven track record in Tier 1 capital project design, assurance, and aseptic process technology leadership.
PMP or equivalent; LEED or sustainability certification preferred.
Strong knowledge of biopharma facility design, aseptic processing, clean utilities, HVAC, and process systems.
Familiarity with ISPE Baseline Guides, ASTM E2500, and risk-based design approaches.
Experience with biologics, cell & gene therapy, or sterile manufacturing facilities.
Proficiency in BIM, AutoCAD, and digital design platforms.
Global mindset and ability to work in a matrix organization

Nice To Haves

Experience with biologics, cell & gene therapy, or sterile manufacturing facilities.
Proficiency in BIM, AutoCAD, and digital design platforms.
Global mindset and ability to work in a matrix organization.

Responsibilities

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.