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- Tasks: Lead quality validation processes and ensure compliance with GMP regulations.
- Company: Join a top UK pharmaceutical employer known for career growth and a great work environment.
- Benefits: Enjoy a competitive salary, 15% bonus, car allowance, and hybrid working options.
- Why this job: Be at the forefront of quality assurance in an innovative pharmaceutical setting.
- Qualifications: 5+ years in GMP validation; degree in science or engineering preferred.
- Other info: Collaborate with global stakeholders and drive process improvements.
The predicted salary is between 36000 - 60000 £ per year.
Location: Surrey, UK (Hybrid)
Package: Salary plus 15% bonus and Car or Car Allowance
My client is a world-renowned pharmaceutical organisation recognised as a top employer in the UK. They offer an excellent working environment with competitive benefits and outstanding opportunities for career development. They now have a pivotal role in ensuring the highest standards of quality at an innovative pharmaceutical manufacturing site.
As a Quality Validation Engineer, you will be at the forefront of the Quality Validation program, focusing on key areas such as Process Validation, Control Strategy, Cleaning Validation, and Hold Time Validation. You will also manage the planning and execution of overall Validation processes for the site. You will ensure validation documentation meets GMP Regulations and company procedures/policies, fostering a culture of compliance throughout the organisation. You will author, review, and execute validation and qualification lifecycle documentation while overseeing site validation activities.
Key Responsibilities
- Drive process improvements and support operations in delivering projects aligned with business needs
- Collaborate across all site functions to ensure compliance with local and company directives
- Create and maintain validation documents and quality strategic documentation
- Manage validation documentation including protocols and reports (URS, FAT, SAT, IOPQ, etc.)
- Generate monthly, quarterly, and annual KPI adherence reports
- Work with all departments to maintain validated status of processes
- Establish strong connections with local validation SMEs and global stakeholders
- Support Quality Management System activities (audits, CAPA, Deviation, Change Control)
- Develop and modify SOPs, Work Instructions, and guidelines for validation policies
About You
- 5+ years in equipment and process validation within a GMP pharmaceutical environment
- Strong understanding of GMP, Risk assessment, and Data Integrity
- Extensive knowledge of validation and qualification processes
- Degree in a related science or engineering field, or formal qualification in validation or quality
- Experience in aseptic production and biologics and/or Project management experience are desirable
If you're interested in the above role then please click apply or get in touch to discuss further.
Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.
Seniority level: Associate
Employment type: Full-time
Job function: Quality Assurance and Engineering
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Quality Validation Engineer employer: Consult
Contact Detail:
Consult Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Validation Engineer
✨Tip Number 1
Familiarise yourself with the latest GMP regulations and validation processes. This knowledge will not only help you in interviews but also demonstrate your commitment to quality standards, which is crucial for a Quality Validation Engineer.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in quality assurance and validation. Attend relevant conferences or webinars to make connections that could lead to referrals or insider information about the role.
✨Tip Number 3
Prepare to discuss specific examples of your experience with process validation and compliance during interviews. Highlight any successful projects where you improved quality or efficiency, as this will showcase your practical skills and problem-solving abilities.
✨Tip Number 4
Research the company’s culture and values, particularly their approach to quality and compliance. Tailoring your conversation to align with their mission can set you apart from other candidates and show that you’re a good fit for their team.
We think you need these skills to ace Quality Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality validation, particularly within a GMP pharmaceutical environment. Emphasise your understanding of validation processes and any specific projects you've managed.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and engineering. Mention specific skills that align with the job description, such as your experience with process validation and compliance with GMP regulations.
Highlight Key Achievements: In your application, include quantifiable achievements related to quality validation. For example, discuss how you improved validation processes or contributed to successful audits, showcasing your impact on previous roles.
Showcase Collaboration Skills: Since the role involves working across various site functions, emphasise your ability to collaborate effectively. Provide examples of how you've worked with different teams to ensure compliance and drive process improvements.
How to prepare for a job interview at Consult
✨Showcase Your Validation Experience
Make sure to highlight your 5+ years of experience in equipment and process validation within a GMP pharmaceutical environment. Be prepared to discuss specific projects you've worked on, focusing on your role in ensuring compliance with GMP regulations.
✨Demonstrate Your Knowledge of GMP and Risk Assessment
Familiarise yourself with the latest GMP guidelines and be ready to discuss how you have applied risk assessment principles in your previous roles. This will show that you understand the importance of quality in the pharmaceutical industry.
✨Prepare for Technical Questions
Expect technical questions related to validation processes, such as Process Validation, Cleaning Validation, and Hold Time Validation. Brush up on these topics and be ready to explain your approach to managing validation documentation and protocols.
✨Emphasise Collaboration Skills
Since the role involves working across various site functions, be prepared to discuss examples of how you've successfully collaborated with different teams. Highlight any experience you have in fostering a culture of compliance and supporting Quality Management System activities.
