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- Tasks: Lead Computer Systems Validation and ensure compliance with regulatory requirements.
- Company: Join a dynamic team at our Livingston site, focused on innovation and quality.
- Benefits: Enjoy opportunities for continuous improvement and professional growth.
- Why this job: Be a key player in driving compliance and making a real impact in the industry.
- Qualifications: Bachelor's degree in a related field and significant experience in Computer Systems Validation required.
- Other info: Ideal for those passionate about quality and regulatory standards.
The predicted salary is between 36000 - 60000 £ per year.
Your Role:
We have an exciting opportunity for a Computer Systems Validation (CSV) Specialist at our Livingston site. In this role, you will lead Computer Systems Validation across the site and support the execution of the Validation Master Plan. You will ensure compliance with regulatory requirements (21 CFR Parts 11, 211, 600, ISO 9001, ISO 13485) and provide guidance on validation issues. Your responsibilities will include participating in investigations for failures, managing CAPA, and driving continuous improvement initiatives while maintaining and updating validation procedures.
You will stay informed on the latest regulatory requirements and support the IT department in Software and Hardware Validation compliance. As a subject matter expert (SME) for GxP systems, you will drive compliance strategies and manage GxP system life cycle activities, including change management and system integration projects.
Who You Are:
- Bachelor’s/Undergraduate Degree in a quality or science-related discipline (chemistry, biology, or medical technology preferred).
- Significant experience in Computer Systems Validation.
- Expertise in GMP, FDA regulations, SOP development, and a strong understanding of Validation and Data Integrity Principles.
- Strong analytical and problem-solving skills, with the ability to present results effectively.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills, capable of collaborating at all organizational levels.
- Ability to work well in a team, taking accountability for actions and contributing to team objectives.
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Computer System Validation Specialist employer: Merck Group
Contact Detail:
Merck Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Computer System Validation Specialist
✨Tip Number 1
Familiarise yourself with the latest regulatory requirements, especially those related to 21 CFR Parts 11, 211, and ISO standards. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and continuous improvement.
✨Tip Number 2
Network with professionals in the field of Computer Systems Validation. Attend industry conferences or webinars where you can meet potential colleagues and learn about the latest trends and challenges in CSV. This can give you valuable insights and connections that may help you land the job.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you've successfully managed CAPA or driven continuous improvement initiatives. Being able to articulate these experiences clearly will showcase your problem-solving skills and your ability to contribute to team objectives.
✨Tip Number 4
Brush up on your Microsoft Office skills, particularly Excel and PowerPoint, as these tools are essential for data analysis and presentations. Being proficient in these applications will help you stand out as a candidate who can effectively communicate results and collaborate across teams.
We think you need these skills to ace Computer System Validation Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Computer Systems Validation and relevant regulatory knowledge. Use keywords from the job description, such as 'GMP', 'FDA regulations', and 'Validation Master Plan' to catch the employer's attention.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about the role and how your background aligns with the responsibilities outlined. Mention specific experiences that demonstrate your expertise in compliance and validation processes.
Showcase Your Skills: Emphasise your analytical and problem-solving skills in your application. Provide examples of how you've successfully managed CAPA or driven continuous improvement initiatives in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role focused on compliance and validation.
How to prepare for a job interview at Merck Group
✨Know Your Regulations
Familiarise yourself with the key regulatory requirements such as 21 CFR Parts 11, 211, and ISO standards. Being able to discuss these regulations confidently will demonstrate your expertise and understanding of the compliance landscape.
✨Showcase Your Experience
Prepare specific examples from your past experience in Computer Systems Validation. Highlight any successful projects or challenges you've overcome, particularly those related to CAPA management and continuous improvement initiatives.
✨Demonstrate Analytical Skills
Be ready to discuss how you approach problem-solving and analysis. You might be asked to provide examples of how you've used data to drive decisions or improve processes, so think of relevant scenarios beforehand.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Since the role requires collaboration across various levels, showcasing your communication skills during the interview is crucial. Consider preparing a few questions to ask the interviewer to show your engagement.
