Aseptic Manufacturing Lead
About the role
KBR Sustainable Technology Solutions (STS) seeks an Aseptic Manufacturing Lead to provide specialized oversight of formulation, sterile filling, aseptic processing, and associated manufacturing systems. The 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.
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 the design and engineering team responsible for meeting project requirements in this area, including 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.
Qualifications
- 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.
Benefits
KBR offers a selection of competitive lifestyle benefits which could include 401K plan with company match, medical, dental, vision, life insurance, AD&D, flexible spending account, disability, paid time off, or flexible work schedule. The company also supports career advancement through professional training and development.