KBI Biopharma
Senior MS&T Engineer – KBI Biopharma
Join to apply for the Senior MS&T Engineer role at KBI Biopharma.
This role offers an exciting opportunity for a skilled engineer to impact the efficiency, quality, and innovation within downstream biologics processing. As the MS&T Senior Engineer – Downstream, you will support cGMP production operations through process engineering, technology transfer, and process 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.
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.
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.
Salary Range $118,000 - $162,800 (actual salary may vary based on qualifications and experience).
Benefits Annual bonus structure, medical, dental, and vision coverage, paid PTO and holidays, 401(k) matching with 100% vesting in 60 days, and employee recognition programs.
About KBI KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That’s why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.
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This role offers an exciting opportunity for a skilled engineer to impact the efficiency, quality, and innovation within downstream biologics processing. As the MS&T Senior Engineer – Downstream, you will support cGMP production operations through process engineering, technology transfer, and process 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.
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.
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.
Salary Range $118,000 - $162,800 (actual salary may vary based on qualifications and experience).
Benefits Annual bonus structure, medical, dental, and vision coverage, paid PTO and holidays, 401(k) matching with 100% vesting in 60 days, and employee recognition programs.
About KBI KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That’s why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.
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