The Opportunity
The Engineer I will apply sound scientific and engineering principles to support customer visits and tours as well as supporting continuous process validation activities. This role will allocate 50% of its time to technical transfer/process validation and 50% to supporting customer visits and tours.
About You
The candidate should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently with minimal direction and have excellent communication skills.
Your Responsibility & Duties
- Supporting Customer Site Visits and Tours
- Compiling process data and communicating out to the client and upper management via production updates and campaign summary reports.
- Compiling process data and supporting continuous process verification
- Supporting investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation
- Supporting collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports
- Assist in tech transfer program deliverables
Minimum Requirements:
- BS or MS in Science or Engineering with minimum of 2 years industry experience (Monoclonal Antibody Manufacturing experience is preferred)
- Working knowledge of downstream processing techniques and equipment in biologics
- Understanding of cGMP compliance requirements
- Experience with manufacturing operations, tech transfers or scale up is a plus
- Experience working in cGMP manufacturing environment is preferred
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
What We Do
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs.
KBI is proud to be a JSR Life Sciences Company.
