MS&T Senior Engineer - Downstream

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 Senior Engineer - 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 directly engaging with clients, you will lead the implementation of process improvements, troubleshoot technical issues, and ensure that client and regulatory standards are consistently met.

This position is ideal for an experienced engineer with a strong 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 Engineering

• Provide technical expertise for cGMP production runs, ensuring efficient and reliable downstream operations.

• Oversee and support the transfer of processes from development to manufacturing, including critical process descriptions and requirement definitions for site implementation.

• Develop and implement process validation, monitoring strategies, and documentation to ensure ongoing compliance and process stability.

Client Communication and Requirement Definition

• Act as the primary point of contact for clients, managing communication to clearly articulate process requirements, expectations, and modifications.

• Facilitate client alignment on process design, transfer plans, and performance criteria, ensuring all production activities meet defined client standards.

Equipment System Ownership

• Support equipment lifecycle management, including procurement, commissioning, qualification, and ongoing maintenance planning.

• Define equipment maintenance requirements, enroll new manufacturing equipment, and evaluate and respond to equipment deviations and change impacts.

Cross-Functional Collaboration and Team Leadership

• Lead cross-functional teams to coordinate 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:

• Bachelor’s degree in science or engineering with a minimum of 9 years of industry experience,

• OR Master’s degree with at least 7 years of industry experience,

• OR PhD with at least 5 years of industry experience.

Skill and Competencies:

• Proven expertise in biologics, specifically in upstream or downstream processing, technical transfer, and operational support.

• Strong background in cGMP production operations is essential.

• Demonstrated experience in technical transfer and scale-up processes.

• Familiarity with process validation and GMP compliance requirements is highly preferred.

• 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 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.