Computer System Validation

2 days ago

Melbourne, Australia Capgemini Engineering Full time

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Key Responsibilities:

- Author and review comprehensive CSV lifecycle documentation, including validation plans, risk assessments, protocols, and reports.
- Ensure compliance with regulatory requirements such as 21 CFR Part 11 and EU Annex 11.
- Collaborate with cross-functional teams to implement and maintain validated laboratory systems and instruments.
- Provide technical expertise in digital network principles, including segmentation, VLANs, and firewall configurations.
- Support and troubleshoot Microsoft Windows environments (client and server) used in laboratory settings.
- Work independently and as part of a team to deliver high-quality validation deliverables on time.

**Required Qualifications**:

- Minimum 5 years of experience in CSV for laboratory instruments and systems.
- Proven track record in authoring and reviewing CSV documentation.
- Strong knowledge of 21 CFR Part 11 and Annex 11 compliance.
- Experience with laboratory systems, instruments, or automation technologies.
- Solid understanding of networking concepts (segmentation, VLANs, firewalls).
- Proficiency in Microsoft Windows environments (client and server).
- Excellent communication and collaboration skills.

Preferred Qualifications:

- Experience in GxP-regulated environments.
- Familiarity with LIMS, ELN, CDS, or other lab informatics platforms.
- Knowledge of data integrity principles and audit trail reviews.

**What you’ll love about working here**:

- We recognise the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance.
- At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
- Equip yourself with valuable certifications in the latest technologies such as AWS and Microsoft Azure.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

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