Senior Validation Engineer

PharmOut Pty Ltd; City of Melbourne; On-site; AUD 120,000 - 170,000; Full time

Job summary

PharmOut Pty Ltd is a leading consultancy focused on validation for life sciences, with opportunities to work across pharmaceutical, medical device, biologicals and GMP manufacturing sectors from Melbourne.

The role seeks experienced validation engineers passionate about O365, SharePoint, Power BI and AI, to develop validation documents and dashboards for diverse clients locally and internationally.

Qualifications

• Tertiary IT, science or engineering qualifications.
• At least 5 years' experience in validation or QA with strong validation exposure.
• Experience in GMP manufacturing environments regulated by EMA, TGA, PIC/S or US FDA.
• Demonstrable GMP writing skills (SOPs, QMS docs, validation plans/protocols/reports).
• Passion for computerised systems.

Responsibilities

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

Skills

Validation experience

GMP knowledge

Computerised systems

Education

Science/Engineering degree

Tools

Power BI

Copilot

Agentic Agents

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)

What can I earn as a Validation Engineer

PharmOut is a rapidly growing international GMP, Validation and Engineering consultancy founded in 2006.

PharmOut has grown a strong reputation for offering leading GMP compliance, validation, regulatory, engineering and architectural consulting services to the pharmaceutical, veterinary or medical device manufacturers, as well as related hospital and pharmacy operations.

We aim to give you a competitive advantage by helping you design, build and operate manufacturing facilities that will fully comply with international Good Manufacturing Practice (GMP) regulations as issued by regulatory agencies such as the US FDA, EU EMA, CFDA and PIC/S member agencies such as the Australian TGA, New Zealand MedSafe, Singaporean HSA to list a few of the nearly 50 agencies.

Source: This is an extract from the company's own website.

PharmOut is a rapidly growing international GMP, Validation and Engineering consultancy founded in 2006.

PharmOut has grown a strong reputation for offering leading GMP compliance, validation, regulatory, engineering and architectural consulting services to the pharmaceutical, veterinary or medical device manufacturers, as well as related hospital and pharmacy operations.

We aim to give you a competitive advantage by helping you design, build and operate manufacturing facilities that will fully comply with international Good Manufacturing Practice (GMP) regulations as issued by regulatory agencies such as the US FDA, EU EMA, CFDA and PIC/S member agencies such as the Australian TGA, New Zealand MedSafe, Singaporean HSA to list a few of the nearly 50 agencies.

Source: This is an extract from the company's own website.