Validation Engineer/Associate
Aegros Therapeutics Pty Ltd, Australia
Job Description
Description
Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.
At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.
Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collected into life saving hyperimmune products.
It's no secret that Aegros is expanding rapidly! An exciting opportunity has arisenfor a Validation Engineer/Associate to join our Validation team.
Reporting to the Head of Validation, you will be responsible for planning, developing, and executing qualification protocols and associated testing based on site guidance and industry standards. With a key focus on improving computer control systems, you will work on preparing, reviewing and implementing high quality reports for executed protocols.
What you will be involved in
- Preparation of Project Validation Plans and participate in planning the validation program of the facility and computerised systems
- Prioritizing, planning and implementing the validation or revalidation programme for the facility
- Coordinating with the Production Manager, Quality Control Manager and Facility Manager in the execution of validation protocols
- Assisting with the specification of the validation requirements for new and or existing GMP automated process equipment, facility, or controlled environment equipment.
- Liaising and assisting Process and Facility and IT Managers in the coordination of the validation activities
- Preparing and reviewing validation protocols and reports required to validate the facility, equipment, and process associated computerised systems
- Executing validation protocols or witness the execution of the validation protocols.
- Writing and reviewing standard operating procedures and work instructions related to the validation activities.
Requirements
What we expect from you:
- A minimum of Bachelor of Science (Chemistry, Microbiology, Engineering, etc.) degree or equivalent
- 4-8 years’ experience working in Validation within pharmaceutical or related industries
- Excellent verbal and written communication skills
- Ability to work independently in fast paced environment
- Well-capable of coordinating with multiple departments.
Benefits
Here’s what we can offer you
- An environment which allows the individual to grow alongside the company
- A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do
- The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved
- A multicultural environment where every voice is heard
- Competitive remuneration package which includes an annual Bonus + Employee Share Options
- Close to public transport.
Interested? Apply today...!