Pharmaceutical Validation Engineer

Evolve Scientific; Brisbane; On-site; AUD 90,000 - 120,000; Part time

Job summary

Evolve Scientific in Brisbane’s western suburbs is seeking an experienced Validation Engineer on a casual ongoing basis for 6–12 months. You will support validation of equipment, facilities and systems within a GMP-regulated environment and contribute to lifecycle management across production areas.

The role requires URS/FS/IQ/OQ/PQ documentation, risk-based change control and strong technical writing. Applicants may need medical assessment and police checks as part of the process.

Qualifications

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

Responsibilities

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

Skills

Validation lifecycle

GMP/regulated environment

Technical writing

Change control/risk management

Documentation (URS/FS/IQ/OQ/PQ)

Project Management Systems

Education

Bachelor's degree in Engineering or Science

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.

Please note:

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.