Senior Validation Engineer

PharmOut; City of Melbourne; On-site; AUD 120,000 - 160,000; Full time

Job summary

PharmOut is seeking experienced validation engineers based in Melbourne to work on validation projects across life science clients. The role focuses on GMP validation, computerised systems and QA documentation in a dynamic consultancy environment.

You will prepare validation documents, validate facilities and equipment, and develop Power BI dashboards with Agentic Agents tools to support compliance and data insights.

Qualifications

• GMP validation experience and knowledge of EMA/TGA/PIC/S or US FDA environments.
• Proven GMP writing skills: SOPs, QMS documents, validation plans and reports.
• Experience with computerised systems and CSV concepts.
• Strong communication and cross-functional collaboration abilities.

Responsibilities

• Preparing and updating a full suite of validation documents across manufacturing aspects.
• Performing facility, services and equipment validation including cleaning and CSV.
• Developing Power BI dashboards and Agentic Agents integration.

Skills

GMP concepts

Quality assurance

Technical writing

Validation principles

Education

Tertiary IT, science or engineering qualifications

Tools

Power BI

Copilot

Agentic Agents

Github

Job description

PharmOut is a leading professional consultancy, specializing in servicing the life science industries. If you are looking for a career to challenge and excite you, PharmOut offers validation professionals varied and stimulating work across a diverse portfolio of clients.

Our core services include architecture and engineering, compliance and validation consulting to health sciences sectors including pharmaceutical, medical device, biologicals, nuclear medicines, pharmacy and blood and tissue manufacturing industries.

We need experienced validation engineers to join our team based in Melbourne who is passionate about O365, SharePoint, Power BI and AI.

As the largest employer of validation professionals in Australia, we offer you great development opportunities, training from world experts and the chance to work with the most prestigious companies locally, nationally and internationally.

We are looking for validation consultants who will be:

• Preparing and updating a full suite of validation documents across as aspects of manufacturing
• Experienced in performing facility, services and equipment validation, including cleaning and CSV
• Developing Power BI dashboards and Agentic Agents (Copilot, Scout and Github)

Applicants should have:

• Tertiary IT, science or engineering qualifications
• At least 5 years' experience in validation, or as a QA or manufacturing professional with a high level of exposure to and understanding of validation concepts
• Previous experience in a GMP manufacturing environment regulated by EMA, TGA, PIC/S or US FDA
• Demonstrable experience and proven skills in GMP technical writing, e.g. SOPs and related QMS documentation, validation plans, protocols and reports.
• Passionate about computerised systems

The following attributes would be highly regarded:

• Experience in specialised GMP fields, such as aseptic or terminal sterilisation processes, non-sterile OSD manufacture, cell therapies or technical transfer
• Passionate about AI, Power BI, Copilot and Agentic Agents
• Computer systems validation and understanding of GAMP.
• Process validation and/or cleaning validation experience
• Ability to travel
• Long term Australian working rights (however, applicants currently in Australia on working tourist visas may be considered for contract roles)