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 Slough employer: Rephine
Rephine is an exceptional employer for those seeking a meaningful career in the Life Sciences sector, offering remote work opportunities from the UK that promote a healthy work-life balance and flexible hours. With a dynamic and multicultural team, employees are encouraged to share their ideas and benefit from continuous learning and career development, all while contributing to critical projects that drive digital transformation in quality assurance and compliance. Join us to make a significant impact in a fast-evolving industry and grow alongside a company that values your expertise and fosters professional growth.
StudySmarter Expert Advice🤫
We think this is how you could land Computer System Validation Consultant in Slough
✨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 hunt for a CSV Consultant role. You never know who might have the inside scoop on job openings 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 regulatory standards. Be ready to discuss your past experiences with validation projects and how you've tackled challenges. We want to see that you can bring your expertise to the table!
✨Tip Number 3
Showcase your soft skills! Communication and interpersonal skills are key in consultancy roles. Practice articulating your thoughts clearly and confidently, as you'll need to engage with clients and stakeholders effectively.
✨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 Rephine and contributing to our mission in the life sciences industry.
We think you need these skills to ace Computer System Validation Consultant in Slough
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 colleagues in your application.
Apply Through Our Website:To ensure your application gets the attention it deserves, apply directly through our website. It’s the best way for us to receive your details and get you into the process smoothly!
How to prepare for a job interview at Rephine
✨Know Your Stuff
Make sure you brush up on your knowledge of CSV, validation processes, and relevant regulations like EU GMP Annex 11 and FDA 21 CFR Part 11. Being able to discuss these topics confidently will show that you're not just familiar with the concepts but can also apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've led CSV projects or provided consultancy services. Highlight your achievements and how you ensured compliance and quality in those projects. This will help demonstrate your capability to handle the responsibilities of the role.
✨Ask Insightful Questions
During the interview, don’t hesitate to ask questions about the company’s current projects or challenges they face in CSV. This shows your genuine interest in the role and helps you understand how you can contribute effectively to their team.
✨Emphasise Soft Skills
Since this role involves client interaction and teamwork, be ready to discuss your communication and interpersonal skills. Share examples of how you've successfully collaborated with multidisciplinary teams or mentored junior consultants, as these are key aspects of the job.
