Process Engineer II

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.

What You Can Expect

• 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.
• 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.

What We Expect

• 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.

You should have the ability to work independently and have excellent communication skills.

Responsibilities:

• 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 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.

Range: $74,000.00 / yr - $102,300.00 / yr

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.