At a Glance
- Tasks: Lead and execute CSV and validation activities for pharmaceutical clients.
- Company: Join Rephine, a leader in quality assurance in Life Sciences.
- Benefits: Competitive salary, remote work, flexible hours, and career development.
- Other info: Join a multicultural team and drive digital transformation in the industry.
- Why this job: Make an impact on critical projects while working remotely in a dynamic team.
- Qualifications: 5+ years in validation, strong understanding of GMP and GxP.
The predicted salary is between 36000 - 60000 £ per year.
At Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, we support Pharmaceutical, Biotech, and Medical Device supply chains globally.
We are looking for a Consultant (L2) – CSV to join our team remotely from the UK. This role is ideal for professionals with experience in validation and CSV projects who want to provide senior-level support to pharmaceutical clients, acting as a trusted consultant and technical reference.
Role Purpose
Provide senior-level support to pharmaceutical clients in CSV, validation, and potentially other GMP-related projects, ensuring compliance and delivering high-quality consultancy services.
Key Responsibilities
- Lead and execute CSV and validation activities (planning, risk assessments, IQ/OQ/PQ, reporting).
- Ensure compliance with GMP, GxP, and Data Integrity requirements.
- Act as the main client contact for validation topics.
- Review and approve validation documentation.
- Provide guidance and mentoring to junior consultants.
- Collaborate with client stakeholders in a consultancy environment.
- Manage project timelines and deliverables to meet client expectations.
Experience & Background
- 5+ years in validation and CSV projects in the pharmaceutical or regulated environment.
- Strong understanding of GMP, GxP, and regulatory expectations (EU GMP Annex 11, FDA 21 CFR Part 11, GAMP5).
- Consulting or client-facing experience is a strong plus.
- University degree in Life Sciences, Engineering, or similar.
Soft Skills
- Excellent communication and interpersonal skills.
- Proactive, structured, and solution-oriented mindset.
- Ability to work independently in remote project setups.
- Comfortable working in multidisciplinary, multicultural teams.
What You Bring
- Experience leading and participating in CSV projects across systems like ERPs, eDMS, eQMS, LIMS, SCADA, EBRs, and pharmacovigilance systems.
- Ability to assess system compliance with global regulatory standards.
- Fluent in English.
Why This Role is for You
- Excited to work with clients on critical projects from a remote location in the UK.
- Comfortable managing technical, regulatory, and client-facing responsibilities.
- Eager to learn and grow in a role exposing you to diverse systems and industries.
Why Choose Rephine
- Competitive Compensation: Salary reflects your experience, plus additional benefits.
- Work-Life Balance: Remote work, flexible hours, shorter Fridays.
- Global Exposure: Multicultural team across multiple countries.
- Dynamic Environment: Young, enthusiastic team where your ideas are valued.
- Opportunities for Growth: Career development, leadership opportunities, and continuous learning.
- Drive Digital Transformation: Work on projects using the latest technologies to optimize quality processes.
For over 20 years, Rephine has helped leading Life Sciences companies improve manufacturing quality processes. Join us to grow your career and make an impact in a fast-evolving, global company.
Applications must be in English.
Computer System Validation Consultant in York employer: Rephine
Rephine is an exceptional employer for those seeking a meaningful career in the Life Sciences sector, offering a dynamic and supportive work culture that values innovation and collaboration. With the flexibility of remote work from the UK, employees enjoy a healthy work-life balance, competitive compensation, and ample opportunities for professional growth and development within a multicultural team. Join us to make a significant impact while working on cutting-edge projects that drive digital transformation in quality assurance and compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Computer System Validation Consultant in York
✨Tip Number 1
Network like a pro! Reach out to your connections in the life sciences field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP, GxP, and CSV processes. Be ready to discuss your past experiences and how they relate to the role at Rephine. Confidence is key!
✨Tip Number 3
Showcase your soft skills! Communication and teamwork are crucial in consultancy roles. Think of examples where you've successfully collaborated with others or resolved conflicts to highlight during your discussions.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining the Rephine team.
We think you need these skills to ace Computer System Validation Consultant in York
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of a CSV Consultant. Highlight your experience in validation and compliance, and don’t forget to mention any specific projects that align with what we do at Rephine.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about the Life Sciences industry and how your skills make you the perfect fit for our team. Keep it concise but impactful!
Showcase Your Soft Skills:We value communication and interpersonal skills just as much as technical expertise. Make sure to include examples of how you've successfully collaborated with clients or mentored junior consultants in your application.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently. Plus, you’ll find all the details you need about the role there!
How to prepare for a job interview at Rephine
✨Know Your CSV Inside Out
Make sure you brush up on your knowledge of Computer System Validation (CSV) and related regulations like EU GMP Annex 11 and FDA 21 CFR Part 11. Be ready to discuss specific projects you've worked on, showcasing your experience in leading validation activities and ensuring compliance.
✨Showcase Your Consulting Skills
Since this role involves client-facing responsibilities, prepare examples that highlight your consulting experience. Think about times when you acted as a trusted advisor or provided guidance to clients, and be ready to explain how you managed project timelines and deliverables.
✨Communicate Clearly and Confidently
Excellent communication is key in this role. Practice articulating your thoughts clearly and confidently, especially when discussing complex topics like risk assessments and validation documentation. Remember, the interviewers will be looking for your interpersonal skills as much as your technical knowledge.
✨Demonstrate Your Proactive Mindset
This position requires a proactive and solution-oriented approach. Prepare to discuss situations where you identified potential issues before they became problems and how you took initiative to resolve them. This will show that you're not just reactive but can also lead projects effectively.
