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- Tasks: Support system development and validation, ensuring compliance and efficiency in IT projects.
- Company: Established pharmaceutical company with a flexible working culture.
- Benefits: Remote work options, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and innovation.
- Why this job: Join a dynamic team and make a real impact on vital healthcare systems.
- Qualifications: Experience with enterprise platforms and strong understanding of CSV processes.
The predicted salary is between 40000 - 50000 £ per year.
A well-established pharmaceutical client is looking for an IT & Validation Specialist to support system development, continuous improvements, CSV and IT projects. The role is responsible for overseeing the full lifecycle of systems, including configuration, change control, validation activities, and coordination with external IT service providers. It also drives the ongoing enhancement of business systems to ensure they remain efficient, compliant, and aligned with organisational growth. The client has a flexible approach with regards to the working arrangement being happy with a mostly remote setup, with visits to the office once every week.
Responsibilities
- Manage end-to-end CSV documentation, including change control, specifications, risk assessments, and qualification deliverables (as applicable).
- Manage the preparation, execution and maintenance of CSV documentation (Change Control, URS, FS, risk assessments, test scripts, IQ/OQ/PQ where applicable).
- Perform and coordinate testing activities of system patches, updates and development activities to support CSV.
- Support the validation lifecycle of systems in accordance with GAMP 5.
- Contribute to IT project delivery through coordination, documentation, and stakeholder engagement.
Coordination, Management & Oversight
- Oversee and coordinate external first-line IT support providers across hardware, software, systems, and user access issues.
- Provide second-line IT support, including system testing, enhancements, technical troubleshooting, and resolution of escalated issues.
- Coordinate device provisioning, onboarding and offboarding processes, and asset management in collaboration with IT service providers.
- Manage IT support tickets, maintain documentation, and develop user guides.
- Support adherence to internal IT and quality standards.
- Contribute to periodic system reviews and audit readiness activities.
- Ensure compliance with data integrity principles, including ALCOA+.
Technical Requirements
- Experience supporting or administering enterprise or SaaS platforms such as CRM, QMS, or ERP systems.
- Strong understanding of CSV - executing test scripts, IQ/OQ/PQ or UAT/Functional, documenting evidence, URS/FS.
- Understanding of databases, interfaces, system integrations and CRM / ERP systems.
- Interest in systems development, automation, or low-code tools is desirable.
- Basic knowledge of networking concepts (LAN, VPN, user access).
- Strong problem solving and analytical skills.
- Ability to communicate effectively with both technical and non-technical stakeholders.
IT Systems Support & Validation Specialist employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land IT Systems Support & Validation Specialist
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and IT sectors. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Show off your skills! Create a portfolio or a personal website showcasing your projects, especially those related to system validation and support. This gives potential employers a tangible look at what you can do, making you stand out from the crowd.
✨Tip Number 3
Prepare for interviews by brushing up on common questions related to CSV and IT support. Practice articulating your experience with system development and troubleshooting. We recommend doing mock interviews with friends or using online platforms to get comfortable.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities that might just be the perfect fit for you. Plus, applying directly shows your enthusiasm and commitment to joining our team.
We think you need these skills to ace IT Systems Support & Validation Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the IT Systems Support & Validation Specialist role. Highlight your experience with system development, CSV documentation, and any relevant IT projects you've worked on. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a great fit. Don’t forget to mention your understanding of compliance and data integrity principles, as these are key for us.
Showcase Your Problem-Solving Skills: In your application, be sure to include examples of how you've tackled technical challenges in the past. We love candidates who can demonstrate strong analytical skills and effective communication with both technical and non-technical stakeholders.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company culture and values!
How to prepare for a job interview at X4 Life Sciences
✨Know Your CSV Inside Out
Make sure you brush up on your knowledge of Computer System Validation (CSV) before the interview. Be ready to discuss your experience with managing documentation like Change Control and risk assessments, as well as how you've executed test scripts in previous roles.
✨Showcase Your Technical Skills
Prepare to talk about your experience with enterprise or SaaS platforms, especially CRM, QMS, or ERP systems. Highlight any specific projects where you contributed to system development or enhancements, and be ready to explain your understanding of databases and system integrations.
✨Communicate Clearly with Examples
Since the role involves liaising with both technical and non-technical stakeholders, practice explaining complex concepts in simple terms. Use examples from your past experiences to demonstrate how you've effectively communicated and resolved issues in a team setting.
✨Be Ready for Problem-Solving Scenarios
Expect some situational questions that assess your problem-solving skills. Think of specific challenges you've faced in IT support or system validation, and prepare to walk the interviewer through your thought process and the steps you took to resolve those issues.