At a Glance
- Tasks: Review and author validation protocols, conduct testing, and ensure compliance in a fast-paced environment.
- Company: Leading pharmaceutical company focused on innovation and quality assurance.
- Benefits: Competitive salary, health insurance, pension contributions, and paid holidays.
- Other info: Fully remote role with opportunities for professional growth and development.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry from anywhere.
- Qualifications: 3-5 years in Computer System Validation with strong protocol authoring skills.
The predicted salary is between 42525 - 51975 £ per year.
Job Description
Are you interested in taking the next step in your career in Computer System Validation in the pharmaceutical industry?
Are you ready to challenge yourself in a highly-regulated and fast-paced environment?
Are you experienced in IT Validation for Gx P and enterprise systems and ready to work fully remote?
You could be the perfect candidate for this opportunity!
Key Responsibilities
- 1. Requirements Analysis and Testability Assessment
- Review URS, FRS, Design Specifications and related documentation to assess completeness, consistency and testability.
- Identify gaps, ambiguities, missing acceptance criteria and traceability concerns prior to test execution.
- Collaborate with Business Analysts, System Owners and Project Teams to clarify functional requirements.
- 2. Protocol Authoring and Review
- Independently author and review validation test protocols aligned with CSA and risk-based validation principles.
- Develop both positive and negative test scenarios based on system risk, intended use and requirement criticality.
- Ensure adequate requirement coverage and traceability within test protocols.
- 3. Dry Run and Test Readiness Activities
- Conduct protocol dry runs in development or lower environments to verify protocol accuracy and completion.
- Identify protocol improvements and requirement gaps before formal qualification testing.
- Support review activities and incorporate feedback from Validation Leads and project stakeholders.
- 4. Controlled Environment Testing
- Execute formal qualification testing in controlled QA environments following approved procedures and validation documentation.
- Independently assess test results and determine compliance against defined acceptance criteria.
- Key Requirements
- Required Experience and Qualifications
- Minimum 3-5 years experience in Computer System Validation (CSV), Computer Software Assurance (CSA) or regulated software testing within a Gx P environment.
- Demonstrated experience independently authoring, reviewing and executing validation test protocols.
- Experience performing protocol dry runs, identifying requirement gaps and refining test coverage.
- Experience reviewing Functional Requirements Specifications (FRS), User Requirements Specifications (URS) and Design Specifications.
- Ability to independently assess functionality against requirements and document testing outcomes with minimal supervision.
- Experience managing deviations, incidents, defects and retesting activities through to closure.
Desirable Experience
- Familiarity with Computer Software Assurance (CSA) and risk-based assurance principles.
- Knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and relevant data integrity guidance.
- Experience testing enterprise systems such as MES, ERP, LIMS, QMS or other regulated business applications.
- Exposure to automation or AI-enabled tools used in testing and validation.
Benefits
- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid holidays
Location
- UK | remote
CSV Test Engineer in London employer: Oxford Global Resources
Join a leading global life sciences organisation in East Grinstead, where you will be part of a dynamic team dedicated to producing high-quality diagnostic and laboratory products. With a strong emphasis on employee development, you will benefit from comprehensive training and career growth opportunities in a supportive work culture that prioritises safety and quality. Enjoy a competitive salary and benefits package while contributing to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land CSV Test Engineer in London
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Oxford Global Resources. 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 Oxford Global Resources.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Oxford Global Resources. 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 Oxford Global Resources is looking for. A tailored application can really make you stand out!
We think you need these skills to ace CSV Test Engineer in London
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 Oxford Global Resources!
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 Oxford Global Resources 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 Oxford Global Resources!
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 Oxford Global Resources, 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 Oxford Global Resources
✨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 Oxford Global Resources 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 Oxford Global Resources’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.
