Facilities and Process Engineer III

Position Description:

• Direct concurrent engineering projects both technical and project management aspects for capital projects while ensuring their success in meeting their respective objectives.
• Technical aspects include Architectural features, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, Automation.
• Collaborate with MS&T and manufacturing teams to design and optimize bioreactor systems and cell culture processes.
• Develop and implement engineering/ test protocols for media preparation, inoculation, fermentation, and scale-up production.
• Troubleshoot and resolve equipment and process-related issues in bioreactor systems.
• Monitor and analyze process data to improve yield, quality, and consistency of upstream processes.
• Oversee equipment operations involving centrifugation, chromatography, filtration, and other purification processes.
• Collaborate with MS&T to optimize downstream processes to ensure high product recovery and purity.
• Support Validations with the development and execution protocols for cleaning and validation of downstream equipment.
• Support the integration of new downstream technologies into existing manufacturing processes.
• Ensure the proper installation, qualification, and maintenance of upstream and downstream process equipment.
• Develop and maintain SOPs (Standard Operating Procedures) and process documentation.
• Partner with equipment vendors and contractors to troubleshoot and resolve technical issues.
• Lead investigations and corrective actions for equipment deviations and failures.
• Project Management aspects include scope definition, scope adherence, stakeholder concurrence, budgeting, scheduling, risk management, procurement and installation support, including coordinating the activities of contract engineers and trade contractors during system modifications/additions.
• Support the Maintenance and Facilities functions for multiple locations including corrective and preventative maintenance and repair of facilities, utilities and equipment.as well as ensuring the facilities comply with all local, state, federal, and corporate guidelines related to health safety and environmental functions
• Support Validation with the planning and execution of commissioning and validation protocols.
• Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis and other Quality Systems.
• Develop and maintain standard operating procedures and other procedures for installed systems.
• Support and comply with engineering standards, drawing controls, project controls and other procedures and standards necessary for the successful operation of the department as well as the creation and maintenance of the same.
• Other assigned duties.
  
  

Job Requirements:

• Bachelor of Science degree in mechanical, chemical, or electrical engineering and a minimum of 7 years of progressively responsible facilities development, facilities construction, and maintenance activities or;
• Bachelor of Science degree in another engineering discipline and a minimum of 9 years of progressively responsible facilities development, facilities construction, and maintenance activities or;
• Bachelor of Science degree in a closely related technical discipline to engineering and a minimum of 11 years of progressively responsible facilities design/development, facilities construction, and maintenance activities.
• Preferred:
• Facilities management experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device industries).
• Incumbents may work with toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment.
• Non-routine week-end work may be required.
• Must comply with all applicable rules and regulations of the company and the Pharmaceutical / Biotech industry including FDA regulations such as cGMP, GDP, Health Safety Environment regulations and company regulations such as the employee handbook. Knowledge of the facilities operation typical to the biotechnology/pharmaceutical industry.
  
  

Salary Range: $84,000 - $115,500

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.

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 is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.