Aseptic Manufacturing Lead

KBR•Newark, DE

About The Position

KBR Sustainable Technology Solutions (STS) provides holistic and value-added solutions across the entire asset life cycle. These include world-class licensed process technologies, differentiated advisory services, deep technical domain expertise, energy transition solutions, high-end design capabilities, and smart solutions to optimize planned and operating assets. KBR is seeking an Aseptic Manufacturing Lead provides specialized oversight of formulation, sterile filling, aseptic processing, and associated manufacturing systems. This role ensures facility designs, equipment selections, and operational strategies support aseptic manufacturing requirements, contamination control objectives, regulatory expectations, and startup readiness while serving as the primary engineering advisor for drug product manufacturing and fill-finish operations. Functional job responsibilities will include but are not limited to: Ensure facility designs, equipment selections, and operational strategies support aseptic manufacturing requirements, contamination control objectives, regulatory expectations, and startup readiness. Serve as the primary engineering advisor for drug product manufacturing and fill-finish operations. Oversee design and engineering team responsible for meeting the project requirements in this area, including but not limited to participation in design reviews.

Requirements

Bachelor’s degree in Engineering or related discipline.
Minimum 10 years of experience with formulation, sterile filling, aseptic processing, and associated manufacturing systems.
Strong knowledge of engineering, design, constructability, operability, and maintainability best practices and code requirements for these systems.
Experience successfully coordinating multidisciplinary engineering and design activities for capital projects in excess of $500M TIC.

Nice To Haves

Experience supporting pharmaceutical, biotechnology, or GMP-regulated facilities.
Prior experience in an Owner’s Representative or PMC role for major capital projects in excess of $1B TIC.
Experience supporting commissioning, qualification, and startup activities.
Professional Engineer (PE) license.

Responsibilities

Ensure facility designs, equipment selections, and operational strategies support aseptic manufacturing requirements, contamination control objectives, regulatory expectations, and startup readiness.
Serve as the primary engineering advisor for drug product manufacturing and fill-finish operations.
Oversee design and engineering team responsible for meeting the project requirements in this area, including but not limited to participation in design reviews.