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: Exciting opportunities for growth and exposure to diverse systems.
- 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 PurposeProvide 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.
- 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.
- 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.
- 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.
- 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.
- 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 Basildon employer: Rephine
Rephine is an exceptional employer for Computer System Validation Consultants, offering a dynamic and supportive work environment that values innovation and collaboration. With the flexibility of remote work from the UK, employees enjoy a healthy work-life balance while engaging in meaningful projects that drive digital transformation in the Life Sciences sector. The company prioritises professional growth through continuous learning and leadership opportunities, making it an ideal place for those looking to advance their careers in a multicultural setting.
StudySmarter Expert Advice🤫
We think this is how you could land Computer System Validation Consultant in Basildon
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Rephine. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Rephine.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Rephine. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Rephine is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Computer System Validation Consultant in Basildon
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Rephine!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Rephine that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Rephine!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Rephine, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Rephine
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Rephine that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Rephine’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
