Job Description

The Opportunity and Job Summary:

This role offers an exciting opportunity for a skilled engineer to impact the efficiency, quality, and innovation within downstream biologics processing at a KBI Biopharma. As the MS&T Engineer II - Downstream, you will be pivotal in supporting cGMP production operations through expertise in process engineering, technology transfer, and validation. Working closely with cross-functional teams and engaging with clients, you will lead/support the implementation of process improvements, troubleshoot technical issues, and ensure that client and regulatory standards are consistently met.

This position is ideal for an engineer with background in downstream processes and biologics, who thrives in a collaborative environment and is committed to driving excellence in manufacturing science and technology. The role offers opportunities for professional growth, exposure to cutting-edge technologies, and a dynamic work environment where your contributions will directly influence production success and client satisfaction.

Your Duties and Responsibilities

• Technical Support and Process Ownership
  • Provide technical expertise for cGMP production runs, ensuring efficient and reliable downstream operations.
  • Support the transfer of processes from development to manufacturing, including critical process descriptions and requirement definitions for site implementation.
  • Perform facility fit activities including process flow diagram generation, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM).
  • Implement process validation, monitoring strategies, and documentation to ensure ongoing compliance and process stability.
  • Compiling/Collecting and analyzing process data and communicating out to the client and upper management via production updates and campaign summary reports.
  • Providing technical support for deviations and process/product impact assessments, change controls, and CAPAs
• Client Communication and Requirement Definition
  • Manage communication to clearly articulate process requirements, expectations, and modifications.
  • Support client alignment on process design, transfer plans, and performance criteria, ensuring all production activities meet defined client standards.
• Cross-Functional Collaboration and Team Leadership
  • Co-ordinate process implementation, validation, and optimization projects.
  • Work closely with Manufacturing, Validation, QA, Facilities & Engineering, Supply Chain, IT, Automation, QC, and Process Development teams to ensure compliant, efficient process execution.
  • Drive effective collaboration to align on process goals, solve complex challenges, and implement improvements.

Your Qualifications

• Educational Background:

BS in Science or Engineering with minimum of 4 years industry experience, Master’s with 2 years industry experience or PhD with no years industry experience.

• Skill and Competencies:
  • Experience in biologics, specifically in upstream or downstream processing, technical transfer, and operational support.
  • Knowledge in technical transfer and scale-up processes.
  • Familiarity with process validation and GMP compliance requirements.
  • Previous experience working in a cGMP manufacturing environment is an advantage.
  • Detail-oriented and organized, with a strong commitment to quality and regulatory compliance.
  • Team-oriented mindset with experience in leading projects and cross-functional initiatives.

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.