Validation Engineer

Evolve Scientific; Ipswich City; On-site; AUD 83,000 - 124,000; Full time

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

About the Role

Our client, a leading pharmaceutical manufacturing company based in Brisbane's western suburbs, is seeking an experienced Validation Engineer to join their team on a casual ongoing basis for 6-12 months, working Monday to Friday, 38 hours per week.

This role will support validation and qualification activities across maintenance/Engineering, Production and Packaging, providing technical expertise for equipment, facilities and systems within a GMP-regulated manufacturing environment.

Applicants will be required to successfully complete a medical assessment, drug screening and police check.

Key Responsibilities

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

Skills & Experience

The successful candidate will have:

• A Bachelor's degree in Engineering, Science or a related discipline.
• Hands-on experience with equipment, facility and/or system validation and qualification.
• Experience with validation lifecycle documentation such as URS, FS, DS, IQ, OQ, PQ and Traceability Matrices.
• Experience working in a GMP manufacturing or highly regulated environment.
• Understanding of risk-based change management/change control.
• Strong technical writing, communication and organisational skills.
• Experience in Manufacturing and working with Project Management Systems.