Business Technology Validation Specialist

CSL Behring King Of Prussia , PA 19406

Posted 2 months ago

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Responsibilities

The BT Validation Specialist will be responsible for ensuring computer systems are validated according to their risk profile and the requirements of the CSL Computer System Validation Master Plan. Assists in risk assessments and the update of software development/implementation lifecycle documents. Oversees testing as require and provides advice and participation in project team activities with respect to the validation of new and existing computerized business applications and other software systems.

Responsibilities:

  • Ensures computer systems are validated according to CSL's Computerized Quality Management System

  • Participates on project teams and supports the validation of business applications and other software systems

  • Trains staff on validation and risk assessments; leads and mentors junior BT Validation staff, as required

  • Leads risk assessments and prepares plans, protocols and reports in line with regulatory requirements and practices

  • Organizes and oversees testing as required

  • Prepare plans, protocols and reports in line with cGxP/ regulatory requirements and practices.

  • Review and approve (as Subject Matter Expert) vendor supplied protocols and reports.

  • Assist in the update of software development / implementation lifecycle documents

Qualifications

Experience:

  • Bachelor's degree or equivalent; education preferably concentrated in IT, Engineering or Science
  • 3-5 years' experience in IT Quality and Validation

Competency:

  • Communicates Effectively

  • Customer Focus

  • Strong organizational, collaborative, and interpersonal skills

Skills:

  • Ability to effectively train others

  • Knowledge of cGxP, GAMP5, and validation practices

#behring #LI-TD1

Capabilities

Worker Type:

Employee

Worker Sub Type:

Regular


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Business Technology Validation Specialist

CSL Behring