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 Manager of Process Engineer, you will act as key 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 provide leadership and subject matter expertise to the manufacturing team(s) on equipment and process capabilities and oversee 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’ll be a coach and mentor, sharing your experiences with the others regarding technical excellence and problem-solving.

· 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 with minimal direction and have excellent communication skills.

Key job responsibilities include:

• Act the system owner and 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.
• Define and 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.
• Responsible for hiring, maintaining employee motivation, counseling, discipline, and overall performance management of the Process Engineering team. You will also provide mentorship to junior engineers, technicians, and associates for equipment design and operation.
• Oversee all administrative and technical aspects of the Process Engineering group to ensure operational efficiency and compliance. Manage KBI engineering resources, including task assignments, work prioritization, and progress reporting.

Qualifications:

• Bachelor of Science degree in Mechanical, Chemical, or Electrical Engineering with:
  • Bachelor of Science degree in mechanical or chemical engineering with minimum of 10+ years industry experience.​
• OR Master of Science degree in Mechanical, Chemical, or Electrical Engineering with:
  • 6-8 years of progressively responsible facilities development, construction, and maintenance experience.
  • 5+ years in the pharmaceutical or biotech industry.
• In-depth knowledge of cGMP requirements.

Recommended Skills:

• Engineering Management experience in a cGMP manufacturing environment (biotech, pharmaceutical, or medical device industries).
• Experience in upstream and/or downstream operations and equipment in biologics
• Experience with GMP compliance requirements and working knowledge of clinical and commercial production, safety standards, and industry best practices
• Proven experience in the design, specification, and FATs for process equipment.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
• Continuous Improvement: Familiarity with Lean, Six Sigma, or other continuous improvement tools is advantageous.
• Extensive experience in process engineering, with a strong focus on drug substance biologics projects. Experience with a solid background may also be considered.
• Experience working with clean utilities.
• Project management techniques and tools
• Strong leadership, technical expertise, and project management skills.

Range: $101,000.00 / yr - $138,600.00 / 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.