Crown Bioscience

Lab and Manufacturing IT System Support Analyst.

Crown Bioscience$83K — $103K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 3+ years experience in a GMP regulated industry
  • Experience in administration of Lab and Manufacturing system applications (e.g., Empower, SoftMax Pro)
  • Solid understanding of GMP applications
  • Basic knowledge of Computer Systems Validation (CSV) process
  • Knowledge of IT system development life cycle and software quality assurance
  • Understanding of general networking concepts and IT best practices
  • Strong verbal and written communication skills

Responsibilities

  • Work within an agile team environment
  • Resolve routine requests including project/folder creation and system backups
  • Provide system administration support for various lab and manufacturing technologies
  • Serve as Subject Matter Expert for lab enterprise systems
  • Lead instrument inductions according to GMP processes
  • Identify and implement root cause solutions for technical issues
  • Implement proactive monitoring to ensure quick recovery and early warnings

Benefits

  • Flexible working arrangements
  • Opportunities for professional development
  • Collaborative team environment
  • Exposure to advanced laboratory technologies
  • Work within a GMP compliance framework
Full Job Description
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 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 or 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 and Manufacturing Systems Support Analyst will be required to serve as the Lead and/or 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. Previous knowledge and experience with Data Integrity remediation and support is a huge plus.

Position Responsibilities
  • Work within an agile team and framework

  • 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 forLaboratoryenterprise systems such as Empower andSoftMaxPro,UV WinLab.

  • Support and or Lead instrument inductions following established GMPprocesses

  • Support business priorities and be flexible to meetdemand

  • Adhere to documented SystemDevelopment Life Cycle as well as relevant regulations, policies, andstandards

  • 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 quickrecovery

  • 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 distributedworkforce

  • Customer-focused and a good communicator

Position Requirements
  • 3+ years of experience in a GMP regulatedindustry

  • 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 theorganization

  • 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

Salary range: 83,040 - 103,800

About Crown Bioscience

Crown Bioscience is a global drug discovery and development services company that specializes in preclinical research. The company was founded in 2006 and is headquartered in Shanghai, China. Crown Bioscience provides a range of services to pharmaceutical and biotechnology companies, including in vitro and in vivo testing, translational oncology, and more. The company has facilities in China, the United States, and Europe. Crown Bioscience is committed to advancing drug discovery and development through innovative research and technology.
Learn more about Crown Bioscience
Size
1,000 employees
Industry
Founded
2006

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