Aseptic Manufacturing Lead
Listed on 2026-11-05
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Engineering
Manufacturing Engineer, Quality Engineering, Occupational Health & Safety, Validation Engineer
K 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.
K 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.
Skills:
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.
Skills:
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.
K 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. We support career advancement through professional training and development.
Belong, Connect and Grow at K
At K , we are passionate about our people and our Zero Harm culture. These inform all that we do and are at the heart of our commitment to, and ongoing journey toward being a People First company. That commitment is central to our team of team’s philosophy and fosters an environment where everyone can Belong, Connect and Grow. We Deliver – Together.
K is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.
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