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April

Computer System Validation Engineer

HALCYON KNIGHTS LOGICMELON - Brisbane Grove, NSW

Any Industry
Source: uWorkin

JOB DESCRIPTION

Position Description

Our Company

Ellume is an Australian-based Health Technology company that develops and manufactures rapid and accurate digital diagnostics for medical practitioners and consumers. We achieve this by integrating next-generation diagnostics, reader technology and software. Our products are distinguished by their simplicity of design, ease of use, rapid time to result and connectivity.

  1. Our Vision:
  2. A world where people return to health as soon as possible.
  3. Our Mission:
  4. Through the creation of simple, accurate diagnostic tools and through the linking of the results of those tools to the best treatment, we help people to get better sooner and enjoy their lives.
  5. Our Purpose:
  6. To create rapid, accurate diagnostic tools that link people to optimal therapy.

The Role

Position title:

Computer Systems Validation Engineer

Reporting to:

Head of Information Systems

Award:

Professional

Level:

Professional 3

Location:

936 Stanley Street

Travel required:

Domestic and international travel to meet and work with contractors or to attend meetings and conferences as needed.

  1. Position summary

The Computer Systems Validation Engineer supports the entire system validation lifecycle including definition of requirements, risk assessments, planning, execution and reporting on testing. The Computer Systems Validation Engineer is responsible for ensuring that Ellume's computer systems are validated and meet FDA and other regulatory body requirements.

Organisational relationships

This position manages the following:

Internal contacts:

  • Managed by the Head of Information Systems
  • Works with various systems project teams and the Quality department

External contacts:

Duties and responsibilities

Responsibility

Standard Required

Systems Assessment

Identify and qualify all computer systems which impact cGMP operations using a risk based methodology

Requirements Analysis

Drive the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met

Protocol execution

Schedule and execute validation plans and tests managing the execution by others where necessary.

Technical Documentation

Develop and maintain:

  • Validation SOPs
  • Validation plans
  • Requirements
  • Risk assessments
  • IQ/OQ protocols test plans, scripts and reports
  • All other deliverables within the scope of the validation plan.

Change Control Management

  • Evaluate proposed changes to validated computer systems and recommend level of validation activities required.
  • Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.

Collaborate on Validation Activities

Communicate with the cross functional teams in a constructive, thoughtful manner to achieve validation objectives

Qualifications

Essential:

  • BS or equivalent degree in math, science or engineering
  • Computer Systems Validation certificate or equivalent experience

Desirable (but not essential):

N/A

Work experience and skills

Essential:

  • 5+ years' experience in computer systems validation.
  • Demonstrated experience:
  • Assisting with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
  • Evaluating proposed changes to validated computer systems and recommending levels of validation activities required
  • Identifying and qualifying all computer systems which impact cGMP operations using a risk based methodology
  • Developing computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
  • Scheduling and executing validation plans and validation documents
  • Ensuring initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
Be able to work closely with the Quality team to ensure appropriate validation of cGMP computer systemsBe highly motivated, organized, and able to manage prioritiesHave the ability to work on multiple concurrent projectsHave the highest standards for quality, accuracy, and professionalismHave excellent communication, presentation, and interpersonal skills

Desirable (but not essential):

Quality and safety

All Employees and Contractors are responsible and accountable for:

  • Compliance with workplace policies for Quality and Safety,
  • Active participation in activities associated with the management of workplace health and safety
  • Active participation in activities associated with the management of quality.

Revision History

Version

Revision date

Author

Changes

A

2020-02-07

  1. Fox

Document Initiation

Signing below signifies agreement to and understanding of the Position Description.

Filed as per SOP013 Training Skills & Education.

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Signature__________________________________________Date________________

Employee name: ___________________________________

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