KBI US Process Engineer III

Job Description

Process Engineering is responsible for all Manufacturing process equipment and ensures the equipment and site infrastructure is in an active state to support cGMP operations.

As a Process Engineer you will act as member of a cross-functional team to support implementation of new systems and improvements to existing manufacturing processes and equipment. You will apply sound scientific and engineering principles to successfully define upstream and downstream process equipment requirements specifications and standards for facility fit and assess equipment design and operation in a commercial cGMP production facility. This may include upstream activities such as cell culture and harvest and/or downstream processes such as chromatography purification and filtration. You will be at the forefront of existing best practices and evaluating technologies. Provide system ownership for Biopharmaceutical process equipment. Identify support and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design specification and supporting the construction startup and validation of process equipment.

Key Responsibilities

• You will support equipment commissioning and qualification activities related to new or modified processes.

• Collaborate with MS&T and Manufacturing teams to troubleshoot and resolve equipment and process-related issues in manufacturing systems.

• Act the technical subject matter expert (SME) for upstream and/or downstream equipment and the site clean utilities ensuring proper installation qualification and maintenance of these systems.

• Lead process engineering related projects to improve manufacturing operations or implementation of new processing equipment. As the project lead you will ensure on time delivery compliance with project requirements and project budget.

• Lead the development scale-up and optimization of upstream (cell culture fermentation) and/or downstream (purification filtration) processes for biologics or advanced therapies

• Design and execute experiments to improve process robustness yield and product quality

• Collaborate with Engineering Quality Regulatory and Manufacturing teams to ensure seamless tech transfer and GMP compliance

• Author and review process documentation including SOPs and Engineering Studies protocols

• Serve as a technical lead in cross-functional project teams and represent process engineering in regulatory filings and audits

• Evaluate and implement new technologies (e.g. single-use systems PAT tools continuous processing) to enhance scalability and efficiency

• Support capital projects including facility design equipment selection and commissioning

• Lead risk assessments and root cause investigations for process deviations

• Communicate with other KBI sites for problem solving and consistency of processes through the organization.

• Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other.

• You will perform facility fit activities for various production scenarios.

• You should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines.

• The ability to manage multiple concurrent projects and resources.

• Lead and support CAPA Change Control Deviation Risk Analysis Root Cause Analysis and other Quality Systems.

• Providing technical support for equipment modifications deviations change controls and CAPAs.

• Develop and maintain equipment SOPs (Standard Operating Procedures) training and other process documentation.

Qualifications:

Bachelors in chemical engineering Biochemical Engineering or related field

5 years of experience in bioprocess development or manufacturing within the biotech or biopharma industry

Expertise in biologics cell therapy gene therapy drug substance production processes

Strong understanding of cGMP regulations FDA/EMA guidelines and validation principles

Proficiency in process modeling and simulation tools

Demonstrated leadership in cross-functional teams and project management

Excellent communication analytical and problem-solving skills

Experience with regulatory submissions (IND BLA MAA) is a plus

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.