Validation Engineer - GMP Manufacturing Specialist

Evolve Scientific

Ipswich City

On-site

AUD 83,000 - 124,000

Full time

2 days ago
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Job summary

Evolve Scientific is seeking a Validation Engineer for a casual ongoing position in Brisbane's western suburbs. The role involves validating equipment, facilities and systems across GMP-regulated operations and supporting lifecycle management, with documentation including URS, FS, IQ, OQ, PQ and related reports.

The successful candidate will hold a Bachelor's degree in Engineering or Science, have hands-on validation experience, and demonstrate strong technical writing and risk-based change

Qualifications

  • Bachelor's degree in Engineering, Science or a related discipline.
  • Hands-on validation/qualification experience across equipment, facilities and systems.
  • Experience documenting URS, FS, DS, IQ, OQ, PQ and Traceability Matrices.
  • Experience in GMP manufacturing or highly regulated environments.
  • Understanding of risk-based change management/change control.
  • Strong technical writing, communication and organizational skills.

Responsibilities

  • Execute equipment, facility and system validation and qualification activities.
  • Develop and execute validation documentation (URS, FS, IQ/OQ/PQ) and validation reports.
  • Support new equipment installations, upgrades and lifecycle management.
  • Provide technical support for equipment changes and risk-based change control.
  • Investigate deviations and support Continuous Improvement initiatives.
  • Ensure activities comply with GMP/cGMP, procedures and safety requirements.

Skills

Validation lifecycle
Technical writing
Communication
Project management systems
GMP experience
Regulatory awareness

Education

Bachelor's degree in Engineering, Science or related discipline

Job description

Evolve Scientific is seeking a Validation Engineer for a casual ongoing position in Brisbane's western suburbs. The role involves validating equipment, facilities and systems across GMP-regulated operations and supporting lifecycle management, with documentation including URS, FS, IQ, OQ, PQ and related reports.

The successful candidate will hold a Bachelor's degree in Engineering or Science, have hands-on validation experience, and demonstrate strong technical writing and risk-based change

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