System Validation Specialist | Melbourne
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|Application Close Date:||15-Jul-2022|
Capgemini is a diverse collective of more than 330,000 strategic and technological experts based across more than 50 countries, partnering with world-renowned clients to transform and manage their businesses. We are dedicated to leveraging cloud, data, AI, connectivity, software, digital engineering, and platforms to address the entire breadth of their business needs. This passion drives a powerful commitment - to unlock the true value of technology.
Over the last 18 months, we have tripled our business in Australia and New Zealand, with over 3,300 team members devoted to helping clients get the future they want. Now is the time to join our rapidly growing team who are at the forefront of finding new ways technology can help us reimagine what's possible, collecting unique career experiences with global brands and game-changing tech projects.
Let's talk about the team:
We are seeking an exceptional individual to join our team and support projects as we evolve the Automotive Industry. Our engineers in the Automotive domain work tirelessly to envision what could be possible, collaborating with peers and stakeholders in order to push the boundaries of technology - making tomorrow's automobile a reality today. When you join the team at Capgemini Engineering, you can get the future you want.
The Computer System Validation Specialist will be responsible for ensuring the Computerized System Validation (CSV) strategy for Computer systems is applied to GxP applications and IT Infrastructure throughout their operational lifecycle.
Let's talk about the role and responsibilities:
- Participate in cross-functional project teams, taking direction from Computer System Assurance resources, provide SME support and guidance to assure validated state of IT platforms and applications.
- Ensure the preparation, delivery, and execution of CSV deliverables meet project timelines.
- Support change controls applied to applications, processes and platforms
- Support close-out activities, support investigation and remediation of defects or deviations during CSV.
- Use Application Lifecycle Management (ALM) platforms to support CSV phases.
Let's talk about your capability and experience:
- 4+ years' experience with CSV methodologies in operation IT, OT, or Automation position with a good understanding of pharma, biologic and chemistry.
- Demonstrated experience working and influencing in a global matrix environment.
- Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity principles.
- Experience with Execution Systems technologies, including Laboratory Information Management Systems (LIMS), Chromatography Data Acquisition System (CDAS), and Laboratory Data Management systems are preferred but not required.
- Experience implementing compliance and risk-based approach best practices.
- Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.
- Experience using ALM platforms such as QC Vera and Codebeamer to support CSV.
Let's talk about what's in it for you!
Capgemini Engineering is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status, or any other characteristics protected by law.
We believe technology is about more than business transformation - it's also about building a more sustainable, inclusive future. This starts with our people, working with you to get the future you want. We invite everyone to bring their whole selves to work, contributing to our inclusive culture and a safe place for our people to be themselves and truly belong. Through championing our staff-led community groups, we are committed to being active allies for everyone. We also aim to build an environment where you can thrive at work and at home. We champion remote working - even though you'll want to check out our beautiful offices - and are in the process of making ‘truly flexible' working arrangements the day-to-day reality for our people. In addition, we strive to ensure your growth and learning experience is unique with access to leading learning platforms, external certifications and opportunities to grow and learn the way you want. Finally, we offer opportunities to use your skills to help society address the impact of the digital and automation revolution, and we're ruthlessly focused on sustainability for our clients and our business - committing to becoming a net zero business by 2030.
We work to recruit and retain a talented and diverse workforce. We strongly encourage applications from suitably qualified candidates regardless of their gender identity, ethnicity, sexual orientation, religion, ability, intersex status or age.
Capgemini Australia has developed and manages, process orientated Management Systems compliant to the requirements of ISO9001, ISO27001 and ISO14001. We are committed to delivering secure solutions and services through state-of-the-art processes and continual improvement frameworks in line with industry best practices as well as contractual, statutory and regulatory requirements.
#GetTheFutureYouWant - Come join us, bring your whole self to work, create new possibilities for you, your customers and your community and help us to be Architects of Positive Futures.
Please note unsolicited resumes from employment agencies or other third parties will not be considered.