At a Glance
- Tasks: Validate and manage computerised systems in a dynamic pharmaceutical environment.
- Company: Leading pharmaceutical manufacturer focused on innovation and compliance.
- Benefits: Competitive salary, career growth, and the chance to work on impactful projects.
- Other info: Private transport required; excellent opportunity for professional development.
- Why this job: Join a team that ensures systems are compliant and fit for purpose in healthcare.
- Qualifications: Bachelor's degree in relevant fields and experience in regulated industries.
The predicted salary is between 82800 - 101200 $ per year.
Our client, a leading pharmaceutical manufacturer, is seeking an experienced Computerised Systems Validation (CSV) Specialist to support validation activities across Production and Packaging operations. This role is responsible for the validation, compliance, and lifecycle management of computerised systems and equipment, ensuring systems remain fit for purpose and compliant within a GMP-regulated environment. Working closely with Production, Engineering, Quality, and Global stakeholders, you will support both new system implementations and existing system upgrades and improvements. This is an excellent opportunity to work on a diverse range of manufacturing systems and contribute to key site projects within a highly regulated pharmaceutical environment.
Key Responsibilities
- Execute CSV activities for standalone and enterprise systems
- Support the lifecycle management of manufacturing, packaging, and computerised systems
- Develop and execute validation requirements for new equipment, systems, and upgrades
- Prepare, review, and maintain validation documentation including protocols, reports, and risk assessments
- Provide technical support for system changes, improvements, and compliance activities
- Manage and support computerised systems projects across the site
- Collaborate with local and global stakeholders on system validation initiatives
- Support continuous improvement projects across Production and Packaging operations
- Assist with the assessment, implementation, and validation of new equipment and systems
- Ensure compliance with GMP, company procedures, data integrity requirements, and health & safety standards
Skills & Experience
- Bachelor's degree in Science, Engineering, Information Technology, or a related discipline
- Previous experience within the pharmaceutical, biotechnology, medical device, or other regulated manufacturing industries
- Experience with CSV, validated systems, and/or GAMP 5 methodologies
- Experience preparing and maintaining validation documentation including validation plans, protocols, and reports
- Understanding of GMP requirements, data integrity principles, and regulated manufacturing environments
- Experience working with manufacturing, packaging, automation, SCADA, MES, ERP, or other computerised systems is highly regarded
- Strong problem-solving, project management, and stakeholder engagement skills
- 3-5+ years' experience in CSV, validation, engineering, quality systems, automation, or regulated manufacturing environments is highly regarded
Computerised Systems Validation Specialist employer: Evolve Scientific
Join a leading pharmaceutical company in the Southeast suburbs of Melbourne, where you will be part of a dynamic team dedicated to quality and compliance. With a strong focus on employee development and a culture that promotes continuous improvement, this role offers meaningful opportunities for growth in a supportive environment. Enjoy the benefits of full-time hours, a collaborative work culture, and the chance to make a significant impact in the pharmaceutical industry.
