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- Tasks: Lead validation activities for life-saving products in a dynamic IT and Quality environment.
- Company: Rapidly growing organisation dedicated to providing life-saving solutions globally.
- Benefits: Competitive salary, bonus scheme, and opportunities for professional growth.
- Why this job: Make a real impact on quality and compliance in a collaborative setting.
- Qualifications: Experience in IT/Engineering/Life Sciences with knowledge of regulatory frameworks.
- Other info: Join a fast-paced team with a commitment to innovation and career progression.
Requirement of 5 days per week onsite near Glasgow.
Lorien’s client, a rapidly growing organisation with bases across the UK and overseas providing life-saving products to people around the globe, is looking to secure the services of a CSV Specialist / Systems Validation Engineer to take ownership of validation activity across multiple regulated systems, working at the intersection of IT, Quality, and Operations. This is a site-based role reporting into the Head of IT, with close collaboration with senior quality representatives and others.
In return, they’ll offer you not only a great bonus scheme, but ongoing opportunities to progress both technically and professionally, the chance to have your voice heard as they evolve and optimise their offerings, and a lot more.
What You’ll Be Doing:
- Coordinating and carrying out validation for both custom-developed and commercial off the shelf systems used across regulated environments.
- Supporting lifecycle management from planning onwards, ensuring documentation and compliance remain watertight.
- Conducting risk assessments to determine validation scope and strategy based on Good Practice relevance.
- Creating and maintaining validation documentation such as user/functional requirements specs/validation planning/protocols/reports/etc.
- Liaising with internal teams and vendors to deliver compliant system implementations aligned to Good Automated Manufacturing Practice and agreed standards.
- Acting as a key contact for audit and inspection activity concerning data integrity and system validation.
- Taking part in DR testing for critical systems and assisting with contingency planning.
- Helping evolve internal policies, templates, and working practices to keep pace with regulatory expectations.
What You’ll Bring:
- Proven background in a similar role/s in IT/Engineering/Life Sciences/similar domains.
- Familiarity with regulatory frameworks including Good Automated Manufacturing Practice and similar relevant offerings.
- Track record of working with both custom and off-the-shelf platforms in regulated (GxP) environments — such as in manufacturing, QC or clinical settings.
- Strong written documentation and stakeholder engagement skills.
- Confidence working across departments and communicating with technical and non-technical audiences.
This is a great chance to join a fast-moving, growth-focused organisation that’s deeply committed to its mission, work in a collaborative environment with influence across multiple business units, and play a pivotal role in ensuring quality, compliance and continuity across core IT systems. Want to know more? Apply now with your latest CV and let’s set up a chat!
Contact Detail:
Lorien Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSV Specialist / Systems Validation Engineer - Glasgow - 50-60K plus bonus
✨Tip Number 1
Network like a pro! Reach out to folks in your industry on LinkedIn or at local meetups. We all know that sometimes it’s not just what you know, but who you know that can land you that CSV Specialist gig.
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of Good Automated Manufacturing Practice and other relevant frameworks. We want you to be the go-to person when they ask about compliance and validation strategies!
✨Tip Number 3
Showcase your documentation skills! Bring examples of your previous work to the interview. We’re talking user specs, validation protocols, anything that highlights your strong written communication and stakeholder engagement skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we’re always looking for passionate individuals ready to make an impact in the life sciences sector.
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the CSV Specialist role. Highlight your experience with validation activities and any relevant regulatory frameworks you've worked with. We want to see how your background aligns with what we're looking for!
Showcase Your Documentation Skills: Since strong written documentation skills are key for this role, include examples of your previous work. Whether it's validation plans or risk assessments, let us know how you've nailed it in the past!
Engage with Stakeholders: Demonstrate your ability to communicate effectively with both technical and non-technical audiences. Share instances where you've successfully liaised with teams or vendors to deliver compliant system implementations. We love a good collaboration story!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at Lorien
✨Know Your Stuff
Make sure you brush up on your knowledge of CSV and systems validation. Familiarise yourself with regulatory frameworks like Good Automated Manufacturing Practice, as well as the specific systems mentioned in the job description. This will show that you're not just interested in the role, but that you understand the technical requirements.
✨Showcase Your Experience
Prepare to discuss your previous roles in IT, Engineering, or Life Sciences. Have specific examples ready that demonstrate your experience with both custom and off-the-shelf platforms in regulated environments. Highlight any successful projects where you coordinated validation activities or improved compliance.
✨Engage with Stakeholders
Since this role involves liaising with various teams, practice how you'll communicate with both technical and non-technical audiences. Think of examples where you've successfully engaged stakeholders and how you ensured everyone was on the same page during a project.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company's approach to validation and compliance. This shows your genuine interest in the role and helps you assess if the company culture aligns with your values. For instance, ask about their current challenges in maintaining data integrity or how they evolve their internal policies.
