At a Glance
- Tasks: Validate and ensure compliance of computer systems in the Pharmaceutical & Life Sciences sector.
- Company: Join ALTEN, a global leader in engineering and technology consultancy.
- Benefits: Enjoy flexible working, private medical insurance, and a supportive team culture.
- Other info: Diverse projects, clear career development, and a commitment to inclusivity.
- Why this job: Make a real impact on innovative projects that shape the future of technology and sustainability.
- Qualifications: Degree in Engineering or equivalent experience in regulated environments.
The predicted salary is between 48231 - 58949 £ per year.
ALTEN is a global engineering and technology consultancy operating across over 35 countries worldwide. We partner with industry leaders across sectors including Aeronautics, Aerospace, Defence, Naval, Automotive, Energy, Rail, IT and many more to deliver innovative engineering solutions that drive technological advancement & support sustainable transformation. Our teams of passionate and agile engineers work on cutting-edge projects that shape the future of technology and sustainability. At ALTEN, we empower talented engineers to innovate, solve complex challenges, and deliver impactful solutions that build tomorrow’s world—today.
As a Computer System Validation (CSV) Engineer, you will join our team to support our activities within the Pharmaceutical & Life Sciences sector. You will support the validation and compliance of GxP-regulated computerised systems across manufacturing, quality and laboratory environments. Working closely with Quality, Engineering, Manufacturing, IT and external vendors, you will ensure systems are fit for purpose, compliant with regulatory requirements and maintain the highest standards of data integrity throughout the system lifecycle.
On Site: Full time
Experience Level: Mid-Level (5-9 years of experience)
Key Responsibilities:
- Plan, coordinate and execute validation activities for new and existing GxP-regulated computerised systems.
- Develop, review and maintain validation documentation including validation plans, protocols, test scripts, risk assessments, reports and traceability matrices.
- Perform system testing, verification and validation activities to ensure compliance with business, quality and regulatory requirements.
- Support audits, inspections and regulatory enquiries through the provision of validation documentation and evidence.
- Assess system changes and contribute to change control activities throughout the system lifecycle.
- Work collaboratively with Quality, Manufacturing, Engineering, IT and external vendors to ensure validation requirements are implemented effectively.
- Support data integrity initiatives and ensure systems remain compliant with applicable regulations and industry standards.
- Contribute to continuous improvement activities, validation procedures and best-practice standards.
Required Skills:
- Computer System Validation (CSV)
- GxP-Regulated Environments
- Validation Planning & Execution
- Requirements Verification & Testing
- Risk Assessments & Traceability Matrices
- Quality Assurance & Compliance
- Documentation Review & Report Writing
- Data Collection, Analysis & Interpretation
- Change Control & Lifecycle Management
- Audit & Inspection Support
- Strong Communication & Problem-Solving Skills
Required Qualifications:
- A Bachelor’s or Master’s degree in Engineering, or equivalent military experience.
- Experience working within a regulated environment supporting validation, quality or compliance activities.
- Experience creating and executing validation deliverables including protocols, test scripts, risk assessments.
- Knowledge of GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
- Experience with regulated systems including ERP, MES, LIMS, Manufacturing Execution Systems or Laboratory Systems.
- Understanding of Data Integrity principles (ALCOA+).
- Experience supporting pharmaceutical, biotechnology, medical device or life sciences organisations.
- Knowledge of Quality Management Systems (QMS), deviation management and CAPA processes.
We bring together entrepreneurial, tech-driven people to deliver innovative solutions for leading companies. At ALTEN, you’ll work on exciting projects, supported by ongoing learning, mentoring, and clear career development tailored to your goals. Join a passionate team and help build tomorrow, today.
- A personalised career path and a rewarding management style
- A huge diversity of engineering projects and industries
- Private Medical Insurance
- Employee assistance programme
- Life insurance & Pension Scheme
- Social atmosphere, regular gatherings & team buildings
- Flexible way of working (role dependent)
We are proud to support the Armed Forces Covenant & actively encourage applications from members of the Armed Forces community, including veterans, reservists, service leavers, and military spouses/partners. We recognise the value of military skills and experience and are committed to ensuring that no applicant is unfairly disadvantaged during our recruitment and selection processes. ALTEN is committed to fostering a diverse and inclusive workplace and values the strength that comes from a global mix of backgrounds and perspectives. We welcome applications from all suitably qualified candidates, regardless of background or protected characteristics under the Equality Act 2010.
If you require any reasonable adjustments during the recruitment process, please let us know. This role may require you to have or be willing to go through Security Clearance. As part of the onboarding process candidates will be asked to complete a Baseline Personnel Security Standard; details of the evidence required to apply may be found on the government website Gov.UK. If you are unable to meet this and any associated criteria, then your employment may be delayed, or rejected. Details of this will be discussed with you at interview.
Computer System Validation (CSV) Engineer in London employer: ALTEN
ALTEN is an exceptional employer that fosters a dynamic and inclusive work culture, where passionate engineers collaborate on innovative projects that shape the future of technology and sustainability. Located in Broughton, employees benefit from a personalised career path, ongoing learning opportunities, and a supportive environment that values diversity and encourages growth. With a range of benefits including private medical insurance, flexible working arrangements, and a strong commitment to the Armed Forces community, ALTEN is dedicated to creating a rewarding and meaningful workplace for all its team members.
StudySmarter Expert Advice🤫
We think this is how you could land Computer System Validation (CSV) Engineer in London
✨Join Engineering Meetups!
Get yourself along to local engineering meetups or tech conferences. These are great places to connect with like-minded folks and industry leaders who might just have a lead on that full-time Computer System Validation (CSV) Engineer role you’re after at ALTEN.
✨Show Off Your Projects!
Don’t be shy about showcasing your engineering projects. Whether it’s a funky app, a mechanical design, or a complex algorithm, having a solid portfolio on platforms like GitHub can really make you stand out. Plus, it gives potential employers at ALTEN a taste of what you can bring to the table!
✨Engage with Online Communities
Dive into engineering forums and online communities, like Reddit or specific engineering Discord channels. Sharing your insights, asking questions, and being active can help you build connections that might lead to job opportunities at ALTEN.
✨Apply Through Company Websites
When you spot a role like Computer System Validation (CSV) Engineer at ALTEN, apply directly through their website. Often, this can show your genuine interest in the company and you might just get noticed quicker than via typical job boards.
We think you need these skills to ace Computer System Validation (CSV) Engineer in London
Some tips for your application 🫡
Showcase Your Technical Expertise:When applying for an engineering role like Computer System Validation (CSV) Engineer, it’s essential to highlight your technical skills. Include any relevant software or tools you're proficient in on your CV—think CAD software, simulation tools, or programming languages. Don't skimp on any engineering projects you've worked on that demonstrate your ability to solve complex problems.
Focus on Results and Impact:In the engineering world, we love numbers and real-world impact. Quantify your achievements wherever possible—like reducing costs by a certain percentage, improving efficiency, or successfully completing a project ahead of schedule. This gives your future employers at ALTEN a clear picture of the value you can bring.
Craft a Compelling Cover Letter:Use your cover letter to express your passion for engineering and explain why you’re drawn to ALTEN specifically. Share what aspects of their work excite you and how your values align with theirs. This is your chance to show a bit of personality while keeping it professional!
Include Relevant Certifications:If you have any engineering certifications, especially ones that are recognised in your field, make sure to feature them prominently on your CV. They demonstrate not just your knowledge, but also your commitment to professional development, which is something we at StudySmarter value highly.
How to prepare for a job interview at ALTEN
✨Brush Up on Core Engineering Principles
Before heading into the interview with ALTEN, make sure you're solid on the fundamental engineering principles relevant to the role. Be ready to discuss concepts such as thermodynamics, fluid mechanics, or structural analysis, depending on the specifics mentioned in the job description. Don’t skip any hands-on projects or coursework; these can be excellent talking points!
✨Show Off Your Problem-Solving Skills
Expect technical questions or case studies during your interview—after all, engineering is all about solving problems! Prepare a few examples of how you've tackled engineering challenges in the past, whether at university or in any practical experience. Practising with mock technical interviews can really help you articulate your thought process and solutions.
✨Relate Your Experience to the Role
In a full-time role, employers like ALTEN want to see that you can adapt and grow within their team. Be ready to discuss how your previous internships, projects, or studies relate directly to the work you'll be doing. Highlight specific experiences that showcase your collaborative skills and how you've successfully worked within a team environment.
✨Know Your Tools and Software
Most engineering roles require familiarity with specific tools and software. Prepare to talk about your proficiency with programmes like AutoCAD, MATLAB, or SolidWorks if they’re relevant to the role. Even better, have examples of projects where you’ve used these tools, as it'll demonstrate your hands-on experience and readiness for the job.
