GMP Manufacturing System Administrator

Position Summary

The “GMP Systems Administrator” supports KBI Biopharma’s Process Development and manufacturing activities by owning and supporting enterprise applications that improve KBI’s ability to execute for our customers. They will be experienced with shop floor automation and operational data management to meet KBI’s expanding data management needs and accelerate our digital transformation. The System Product Owner will work with internal and external parties to define requirements for new functionality and provide technical direction and expertise for providing that functionality. Additionally, they will have a good understanding of biopharmaceutical processing and development within a regulated environment.
 

What you’ll do:

• Monitor and maintain assigned application(s) in their proper operating condition to meet business requirements.
• Build, prioritize and maintain a backlog of product features/improvements. Ensure constant clarity in terms of what is to be executed next by the development/configuration team.
• Identify, develop, and deploy upgrades to improve operational efficiency and business processes.
• Provide escalated support, and manage vendor support, for assigned applications.
• Stay current on training and administration of SOPs and training activities as part of operating in a validated environment.
• Support the product's deployment to end-users. Collect end-user and other stakeholder's feedback and alter the product's roadmap to take their feedback into account.
• Develop (if needed) and manage user training for product use/access, if applicable.
• Communicate information that is valuable to the intended audience.
• Translate business needs into actionable requirements.
• Lead and provide direction for operational activities as well as project-based support.
• Provide technical expertise in the assigned software applications.
   

What you’ll have:

• Bachelor’s degree in computer science, information technology, or related field. Or significant related experience.
• Minimum of 5 years of experience with GMP and/or quality systems with a preference in the following: OSIPI data historian, MPCS, PLC and/or other GMP automation/MES systems and applications.
• Required 3-5 years’ experience with OSIPI data historian implementation, configuration, and/or administration.
• Experience working in a regulated environment such as pharma/biopharma with exposure to computer systems validation and data integrity requirements
• Exceptional communication, and interpersonal skills.
• Experience with Agile methodology and JIRA applications Product Owner roles and responsibilities.

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.