Pharmaceutical Validation Engineer

Evolve Scientific; City of Brisbane; On-site; AUD 90,000 - 130,000; Full time

Job summary

Evolve Scientific in Brisbane's western suburbs is seeking an experienced Validation Engineer to support validation and qualification activities across maintenance, production and packaging in a GMP-regulated environment. The role is casual ongoing for 6–12 months, Monday to Friday, 38 hours per week.

You will develop and execute validation documentation (URS, FS, IQ, OQ, PQ), support new equipment installations and lifecycle management, and provide technical support for changes.

Qualifications

• Bachelor's degree in Engineering, Science or related field.
• Hands-on validation/qualification experience in GMP.
• Experience with URS, FS, DS, IQ, OQ, PQ and Traceability Matrices.
• Experience in a GMP manufacturing or regulated environment.

Responsibilities

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

Skills

Validation experience

GMP knowledge

Technical writing

Communication skills

Organisational skills

Project management

Education

Bachelor's degree

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.

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