Senior Engineer, Manufacturing Sciences

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 Ownership: Provide technical expertise for cGMP production runs ensuring efficient and reliable downstream and support the transfer of processes from development to manufacturing including critical process descriptions and requirement definitions for site 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 client alignment on process design transfer plans and performance criteria ensuring all production activities meet defined client standards.
• Cross-Functional Collaboration and Team Leadership: Lead cross-functional teams to coordinate process implementation validation and optimization closely with Manufacturing Validation QA Facilities & Engineering Supply Chain IT Automation QC and Process Development teams to ensure compliant efficient process effective collaboration to align on process goals solve complex challenges and implement improvements.

Your Qualifications

• Educational Background: Bachelors degree in science or engineering with a minimum of 9 years of industry experienceOR Masters degree with at least 7 years of industry experienceOR 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 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 experience working in a cGMP manufacturing environment is an -oriented and organized with a strong commitment to quality and regulatory -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.