Job Description

Position Summary:

We are looking for an Engineer II to join our engineering team and support the manufacturing equipment at our biopharmaceutical manufacturing facility. In this role, you will be responsible for maintaining, optimizing, and troubleshooting key equipment, including UFDF (Ultra-Filtration/Diafiltration) systems, Centrifuges, Homogenizers, Fermenters, and other process equipment. You will work closely with cross-functional teams to ensure the systems operate efficiently, reliably, and in full compliance with cGMP (current Good Manufacturing Practices) and regulatory standards.

Manufacturing Equipment Management:

• Support the operation, maintenance, and troubleshooting of manufacturing equipment such as UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps, and Heat Exchangers.
• Optimize system performance to improve equipment efficiency and reduce downtime.

Deviation Investigations:

• Lead investigations into equipment-related Deviations, identifying root causes and contributing to the development of corrective and preventive actions (CAPA).
• Document findings and ensure timely resolution through the Quality Management System (QMS) process.

Change Management:

• Lead engineering changes to manufacturing equipment, following Change Control procedures.
• Lead the planning, execution, and documentation of equipment changes to minimize operational impact and ensure compliance.

System Performance Optimization:

• Assess equipment performance and reliability, identifying opportunities for improvements.
• Work with senior engineers to implement strategies for equipment optimization, reliability improvements, and performance monitoring.

Regulatory Compliance:

• Ensure the manufacturing equipment operates in compliance with cGMP and other regulatory requirements.
• Support the creation and revision of Standard Operating Procedures (SOPs) for equipment maintenance, operation, and troubleshooting.

Cross-Functional Collaboration:

• Collaborate with operations, quality, validation, and manufacturing teams to ensure seamless equipment operation and troubleshooting.
• Work with external suppliers and contractors to support equipment maintenance, repairs, and upgrades.

Documentation and Reporting:

• Maintain accurate records of engineering activities, including maintenance work, investigations, corrective actions, and changes to equipment or processes.
• Ensure all documentation is thorough, cGMP-compliant, and audit-ready.

Requirements:

Education:

• Bachelor’s degree in Engineering, Biotechnology, Biochemical Engineering, or a related discipline.

Experience:

• At least 2-4 years of engineering experience in a biopharmaceutical manufacturing environment.
• Hands-on experience with manufacturing equipment such as UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps, and Heat Exchangers is highly preferred.
• Experience with troubleshooting and maintaining complex manufacturing equipment is a plus.

Technical Skills:

• Familiarity with biopharmaceutical manufacturing processes and equipment.
• Basic knowledge of cGMP regulations and industry standards for equipment maintenance and operations.
• Experience with Quality Management Systems (QMS), Change Control, and CAPA processes is an advantage.
• Proficiency in engineering software, including Microsoft Office Suite and other relevant tools.

Problem-Solving and Analytical Skills:

• Strong troubleshooting skills and ability to perform root cause analysis for equipment-related issues.
• Ability to assist in the development and implementation of corrective actions and process improvements.

Communication Skills:

• Good verbal and written communication skills, with the ability to interact effectively with internal teams, vendors, and contractors.

Team Collaboration:

• Ability to work well in a team environment and collaborate with cross-functional groups to support manufacturing goals.

Attention to Detail:

• Strong attention to detail in equipment maintenance, documentation, and compliance with regulatory standards.

Preferred Skills:

• Experience with process automation or control systems in a biopharmaceutical setting.
• Familiarity with troubleshooting and maintaining process control systems is a plus.
• Experience in a regulated industry, particularly in pharmaceuticals or biotechnology.

Note: This role is a full time onsite position is not hybrid or remote.

Salary Range: $72,282 - $99,388

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

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.