At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

Position Summary: We are seeking a skilled and experienced Maintenance Technician III to join our team and support the maintenance of manufacturing equipment at our biopharmaceutical manufacturing facility. In this hands-on role, you will perform advanced maintenance, troubleshooting, and optimization tasks for critical equipment, including UFDF (Ultra-Filtration/Diafiltration) systems, Centrifuges, Homogenizers, Fermenters, and other process equipment. You will play a key role in ensuring manufacturing systems operate efficiently, reliably, and in compliance with cGMP (current Good Manufacturing Practices) and regulatory standards.

Responsibilities:

• Equipment Maintenance and Troubleshooting:
• Perform advanced maintenance, repair, and troubleshooting of manufacturing equipment, including UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps, and Heat Exchangers.
• Conduct preventive maintenance and system inspections to ensure equipment reliability and minimize downtime.
• Optimize equipment performance to meet operational and regulatory requirements.
• Deviation Investigations and Documentation:
• Assist in investigations of equipment-related deviations and provide input for root cause analysis.
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).
• Document findings and corrective actions in the Quality Management System (QMS).
• System Performance and Process Optimization:
• Continuously monitor and improve the performance and efficiency of manufacturing equipment.
• Perform data analysis to identify trends and implement improvements to enhance equipment reliability and productivity.
• Compliance and Safety:
• Ensure compliance with cGMP, safety, and environmental standards in all maintenance activities.
• Maintain accurate and up-to-date records of maintenance activities, ensuring audit readiness.
• Cross-Functional Support:
• Work closely with operations, quality assurance, and validation teams to ensure seamless equipment functionality.
• Collaborate with external contractors and suppliers for equipment repairs and upgrades as needed.
  
  
  

Requirements:

• Education: High school diploma or equivalent; additional technical certifications in mechanical or electrical systems are a plus.
• Experience:
• Minimum of 10 years of maintenance experience in a biopharmaceutical or similar regulated environment.
• Expertise in working with UFDF systems, Centrifuges, Homogenizers, Fermenters, Valves, Pumps, and Heat Exchangers.
• Skills and Knowledge:
• Strong understanding of cGMP standards and regulatory compliance.
• Proficient in troubleshooting and repairing complex process equipment.
• Ability to read and interpret technical manuals, schematics, and engineering drawings.
• Communication and Teamwork:
• Strong interpersonal and communication skills with a collaborative mindset.
• Ability to work independently and as part of a team in a fast-paced environment.
• Attention to Detail:
• Meticulous attention to accuracy in documentation and maintenance processes.
  
  
  

Note: This is a full-time, onsite position and is not hybrid or remote.

Salary Range: $30.29 - $41.78/hour

About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com..

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.