MS&T Engineer II / III- Upstream

Position Summary

The MS&T Engineer II/III is responsible for providing technical support for cGMP production runs, tech transfer activities, process engineering, process validation, process monitoring, and biopharmaceutical processes in the cGMP manufacturing facility.

The MS&T Engineer interfaces with client organizations to enable clear process description and requirement definition for site implementation.

The MS&T Engineer is also responsible for supporting manufacturing equipment system ownership activities such as procuring and enrolling manufacturing equipment, defining equipment maintenance requirements, equipment commissioning and qualification activities, and evaluating deviations and change impacts.

The MS&T Engineer is responsible for working cross-functionally with Manufacturing, Validation, QA, Facilities & Engineering, Supply Chain, IT, Automation, QC, Process Development as necessary to ensure process implementation and execution is validated and compliant.

Position Responsibilities

• Support technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates, and define equipment selection
• Prepare/review technical documents including supporting batch records, formulation/solution/media records, item specifications, project reports, and engineering specifications
• Support technical deviation investigations and collaborate with operations, technical and quality management to determine event impact, perform root-cause analysis, and corrective action identification
• Compile and analyze process data and communicate to client and upper management via production updates and campaign summary reports
• Supporting/leading collaboration on strategic projects or studies with external & internal partners and presents results in technical reports
• Assist in the Bill of Materials (BOM) generation for new process introductions as well as updating BOMs for process modifications
• Author material specifications in accordance with compendia requirements and grade requirements for introduced process
• Author, qualify, and manage Unicorn methods
• Present and defend procedures, validation, and exceptions in audits and inspections

Position Requirements

• BS in Science or engineering with minimum of 4 years industry experience or Masters with 2 years industry experience or PhD with no experience
• Previously proven competency in upstream biologics, including experience with fermentation and cell culture

Salary: Engineer II- $80,000-$95,000

Engineer III- $100,000-$115,000

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. 

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.