Lab and Manufacturing IT System Support Analyst

Position Summary

The Lab and Manufacturing Systems Support Analyst will provide IT support for KBI Biopharma’s laboratory and manufacturing environments and be the primary contact for issues related to Lab and Manufacturing Systems as they relate to IT.

The position requires basic IT skills in networking, hardware, databases, and operating system level knowledge. The Analyst will support various technologies including Empower, Soft Max Pro, Unicorn, Mass Lynx, Chemstation, SoloVPE, 32

Karat, UV Win Lab, Pharm Spec, and Compass technologies. The Analyst will resolve routine requests such as project/folder creation, system backups, and account requests, as well as troubleshoot and resolve complex issues related to Lab Systems.

Responsibilities also include serving as the Lead and/or Subject Matter Expert (SME) on projects for installation, validation, and deployment of laboratory and manufacturing systems. The Analyst will assist in the writing and execution of CSV deliverables and may support Data Integrity remediation and support.

• Work within an agile team and framework.
• Resolve routine requests including project/folder creation, system backups, and account requests.
• Provide system administration support for technologies such as Empower, Soft Max Pro, Unicorn, Mass Lynx, Chemstation, SoloVPE, 32
  
  Karat, UV Win Lab, Pharm Spec, and Compass.
• Serve as the SME for Laboratory enterprise systems such as Empower and Soft Max Pro, UV Win Lab.
• Support and lead instrument inductions following established GMP processes.
• Support business priorities and remain flexible to meet demand.
• Adhere to the documented System Development Life Cycle and relevant regulations, policies, and standards.
• Lead and support identifying root causes and implement permanent solutions to prevent future occurrences.
• Implement proactive monitoring to ensure early warnings and quick recovery.
• Effectively communicate with all cross‑functional areas regarding applicable IT tasks and deliverables.
• Support the Lab and Manufacturing IT System Support team across multiple offices with a distributed workforce.
• Maintain a customer‑focused approach and strong communication skills.

• 3+ years of experience in a GMP regulated industry.
• Experience in system administration of Lab and Manufacturing system applications (e.g., Empower, Soft Max Pro, UV Win Lab, Unicorn).
• Solid understanding of GMP applications.
• Basic knowledge of Computer Systems Validation (CSV) process.
• Knowledge of the IT system development life cycle and software quality assurance in a regulated environment.
• Knowledge of general networking concepts and IT best practices.
• Ability to work independently and with teams at various levels in the organization.
• Strong verbal and written communication skills, capable of presenting appropriate information to management.
• Strong analytical and organizational skills.

Salary range: 83,

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.