Senior Lab and Manufacturing IT System Support

KBI Biopharma•Boulder, CO

About The Position

The Sr. 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 will require basic IT skills in relation to networking, hardware, databases, and operating system level knowledge. The Lab and Manufacturing System Support Analyst will support various technologies used throughout the lab and manufacturing environments including but not limited to: Empower, SoftMax Pro, Unicorn, MassLynx, Chemstation, SoloVPE, 32Karat, UV WinLab, PharmSpec, and Compass technologies. The position requires a working knowledge of the aforementioned lab and manufacturing systems, and the ideal candidate should have prior experience in administration and the end-use of at least some including at least some of these systems and the instruments which they support. The Lab Systems Support 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 Lab Systems. The position will require interaction with end-users to ensure that all end-user requests are fulfilled, and issues are resolved in a timely manner. The Lab Systems Support Analyst must be customer-focused and a good communicator. The Lab Systems Support 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.

Requirements

BS - in Life Sciences, Engineering or IT related discipline
4+ years of experience in a GMP regulated industry
Experience in system administration of Lab and Manufacturing system applications (i.e.: Empower, SoftMax Pro, UV WinLab, 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 both independently and with teams at various levels in the organization
Strong communication skills, both verbal and written as well as capable of presenting the right level of information to management
Strong analytical and organizational skills

Responsibilities

Resolve routine requests that may include project/folder creation, system backups, account requests
System Administrator providing Support to various technologies used throughout the lab and Manufacturing environments including but not limited to: Empower, SoftMax Pro, Unicorn, MassLynx, Chemstation, SoloVPE, 32Karat, UV WinLab, PharmSpec, and Compass technologies.
Be the Subject Matter Expert for Laboratory enterprise systems such as Empower and SoftMax Pro, UV WinLab.
Support and or Lead instrument inductions following established GMP processes
Support business priorities and be flexible to meet demand
Adhere to documented System Development Life Cycle as well as relevant regulations, policies, and standards
Lead and Support Identifying the root cause of issues and implementing permanent solutions to prevent future occurrences.
Support and Drive Implementing proactive monitoring to ensure early warnings and quick recovery
Effective communicator with all cross-functional areas regarding applicable IT tasks and deliverables
Support Lab and Manufacturing IT System Support team across multiple offices with a distributed workforce
Customer-focused and a good communicator