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Manufacturing Systems Analyst
Boulder, CO
Job Description
Position SummaryThe Manufacturing Systems Analyst supports manufacturing capability by acting as the functional Information Technology Subject Matter Expert in the delivery and support of manufacturing solutions in accordance with company strategy. This position will support manufacturing operations in both Boulder, CO and The Woodlands, TX. The position must have a detailed understanding of Biopharmaceutical Processing and Cell Therapy and how the lab instruments and manufacturing systems support these manufacturing operations. Manufacturing systems include Unicorn Control Software, OSI Pi Historian, SCADA, Client, Chromatography Skids, Bioreactors and Fermenters.The Manufacturing Systems Analyst will be required to resolve routine requests that may include project/folder creation, system backups, account requests, etc.; as well as troubleshooting and resolution of complex issues related to Manufacturing Systems. The position will require the interaction with end users to ensure that all end-user requests are fulfilled and issues are resolved in a timely manner. The Manufacturing Systems Analyst must be customer focused and a good communicator.The Manufacturing Systems Analyst will be required to serve as the Subject Matter Expert (SME) on Projects relating to the installation, validation and deployment of laboratory and manufacturing systems. The position requires basic knowledge of the Computer Systems Validation (CSV) process and will assist in the writing and execution of CSV deliverables as required.
Position Responsibilities
- Install, configure, qualify, and support Lab and Manufacturing focused IT products and solutions for biopharmaceutical manufacturing plant systems
- IT support for GMP qualification requirements with regards to manufacturing systems IT execution requirements
- Responsible for the development and delivery of IT services and helpdesk resolutions regarding site Manufacturing systems and maintenance schedules as required by management /business need
- IT department point of contact for customer inquiries and requests related to Manufacturing Systems
- Network protocol support, systems maintenance and optimization for IT Manufacturing system
- Evaluate system and hardware alignment with the KBI infrastructure based on the customer needs
- Maintain and implement improvements for the site's Lab and Manufacturing infrastructure environment.
- Bachelor's degree or equivalent in IT or Scientific discipline
- Minimum of 1-4 years of experience in biopharmaceutical, manufacturing, or related field
- Experience in validated environments and working in clean room facilities is desirable
- Experience supporting Manufacturing control systems is preferred, as well as any experience with data historian systems
- *Prior experience in a GxP environment is desirable
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.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
1 to 4 years
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