Job Description

Position Summary:

We are seeking a motivated Engineer I to join our engineering team and provide support for the manufacturing equipment at our biopharmaceutical manufacturing facility. In this entry-level position, you will assist with the maintenance, troubleshooting, and optimization of key manufacturing equipment, including UFDF (Ultra-Filtration/Diafiltration) systems, Centrifuges, Homogenizers, Fermenters, and other process equipment. You will work closely with experienced engineers and cross-functional teams to ensure the efficient and compliant operation of the manufacturing systems, while adhering to cGMP (current Good Manufacturing Practices) and regulatory standards.

Responsibilities:

Manufacturing Equipment Support:

• Assist with the operation, maintenance, and troubleshooting of manufacturing equipment, including UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps, and Heat Exchangers.
• Perform routine maintenance tasks, inspections, and assist with repairs to ensure equipment is functioning properly.
• Support equipment performance monitoring and help identify opportunities for improvement.

Deviation Investigations:

• Assist in investigating equipment-related Deviations, including supporting root cause analysis.
• Help document findings and assist in the development of corrective and preventive actions (CAPA) to address issues.
• Support compliance with the Quality Management System (QMS) during investigations and resolution processes.

Change Management:

• Support engineering change activities, including maintaining records and assisting with the documentation of changes to manufacturing equipment.
• Help ensure changes are implemented according to standard procedures and regulatory requirements.

System Performance Monitoring:

• Monitor equipment performance and assist in identifying and implementing improvements to optimize system efficiency and reliability.
• Work with senior engineers to support preventive maintenance programs and contribute to performance reviews.

Regulatory Compliance:

• Ensure equipment operations and maintenance are compliant with cGMP and other relevant regulatory standards.
• Assist in the creation and revision of Standard Operating Procedures (SOPs) for equipment maintenance and operation.

Cross-Functional Collaboration:

• Work alongside operations, quality, and manufacturing teams to support equipment reliability and address any issues.
• Collaborate with external vendors and contractors to support equipment maintenance and repairs.

Documentation and Reporting:

• Maintain accurate and organized records of engineering activities, including maintenance work, investigations, and any changes to equipment or processes.
• Ensure all documentation complies with cGMP and is available for audits.

Requirements:

Education:

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

Experience:

• 0-2 years of engineering experience in a biopharmaceutical manufacturing or related field.
• Familiarity with basic manufacturing equipment, such as pumps, valves, centrifuges, or filtration systems, is a plus.
• Experience in troubleshooting or maintaining equipment in a manufacturing setting is preferred, but not required.

Technical Skills:

• Basic understanding of biopharmaceutical manufacturing processes and equipment is desirable.
• Familiarity with cGMP regulations and industry standards is a plus.
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, etc.) and basic engineering software tools.

Problem-Solving and Analytical Skills:

• Strong willingness to learn and apply problem-solving techniques in troubleshooting and maintenance.
• Ability to work with more experienced engineers to analyze issues and implement effective solutions.

Communication Skills:

• Good verbal and written communication skills, with the ability to engage effectively with team members and other departments.

Team Collaboration:

• Ability to work effectively in a team environment and contribute to the achievement of department goals.

Attention to Detail:

• Strong attention to detail in performing tasks, maintaining accurate records, and ensuring compliance with procedures and standards.

Preferred Skills:

• Familiarity with process control systems, automation, or instrumentation in a manufacturing environment is a plus.
• Previous internship or co-op experience in a related field is desirable.
• Knowledge of basic mechanical, electrical, or automation systems is an advantage.

Salary Range: $66,400 - $84,500

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.