Computer Systems Validation Specialist

4 days ago

Melbourne, Victoria, Australia PSC Biotech Corporation Full time

Job Title: Computer Systems Validation Engineer

Job Summary:

The Computer Systems Validation Engineer will play a crucial role in ensuring the integrity and compliance of computer-based systems within our organization. This position requires a strong understanding of regulatory requirements and the ability to develop and implement effective validation protocols.

Key Responsibilities:

  • Develop and implement validation protocols for computer-based systems
  • Conduct thorough reviews of validation documentation to ensure compliance with regulatory requirements
  • Collaborate with cross-functional teams to identify and address validation gaps
  • Stay up-to-date with advances in the field and regulatory requirements
  • Provide recommendations for process upgrades and improvements in efficiency
  • Support the implementation of improvements with upper management
  • Participate in internal audits and external inspections as required

Requirements:

  • Bachelor's Degree in Computer Science or Engineering or equivalent experience
  • 2-5 years of experience in computer systems validation
  • Demonstrated strategic thinking, implementation skills, and ability to drive results
  • Strong attention to detail
  • Ability to follow protocols and procedures
  • Excellent written and oral presentation and communication skills
  • Highly organized in planning and time management, with the ability to multi-task
  • Ability to work with team or independently
  • Experience writing, reviewing, and executing validation documentation, IQ, OQ, PQ, RTM, Test Scripts, Summary Reports
  • Knowledge of operating systems and MS Office desired
  • Knowledge of regulatory, compliance, and validation desired

About PSC Biotech Corporation:

PSC Biotech Corporation is a leading provider of innovative solutions in the biotechnology industry. We are committed to maintaining the highest standards of quality and integrity in our products and services.

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