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- Tasks: Lead product and process validation in a dynamic pharmaceutical environment.
- Company: Join a leading pharmaceutical company in Leicestershire with a focus on innovation.
- Benefits: Competitive salary, career development, and a supportive team culture.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring product quality.
- Qualifications: Degree in Life Science or Engineering and experience in GMP process validation.
- Other info: Exciting opportunities for growth and collaboration with industry experts.
The predicted salary is between 40000 - 50000 £ per year.
We are currently looking for a Validation Specialist (Manufacturing Support) to join a leading pharmaceutical company based in the Leicestershire area. As the Validation Specialist (Manufacturing Support), you will be responsible for product and process validation, owning PPQ campaigns, and ensuring robust CPV for commercial products at our Charnwood site. You will ensure processes remain in a validated state and inspection‑ready at all times, partnering closely with Manufacturing Operations and the wider Technical Operations Group to turn science and data into compliant, reliable supply and support investigations where required.
KEY DUTIES AND RESPONSIBILITIES
- Lead PPQ: Author/approve protocols, define sampling plans and acceptance criteria, oversee execution, analyse data, and issue PPQ summary reports for timely release.
- Lead or participate in equipment and facility qualification: Deliver qualification lifecycle for GMP relevant equipment using DQ–IQ–OQ-PQ and maintain equipment in a validated state through periodic review and scheduled requalification.
- Lead or participate in new technology and/or process selection. With Technical Operations and Quality, generate URS, review and approve functional/technical specifications, Quality Risk Assessment, Traceability Matrix, IQ/OQ protocols and summary reports.
ROLE REQUIREMENTS
- Relevant degree in a Life Science or Engineering subject.
- Proven industry experience in process validation in GMP drug product (OSD), including PPQ leadership and CPV.
- A working knowledge and practical experience with regulatory guidelines such as FDA 2011 PV, EU GMP Annex 15, and ICH Q8/Q9/Q10.
Validation Specialist in England employer: Hyper Recruitment Solutions
Contact Detail:
Hyper Recruitment Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Specialist in England
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their validation processes and be ready to discuss how your experience aligns with their needs. We want you to shine!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to build confidence. Focus on articulating your experience with PPQ and CPV clearly, as these are key areas for the Validation Specialist role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace Validation Specialist in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Validation Specialist role. Highlight your experience in process validation and any relevant qualifications. We want to see how your background aligns with our needs!
Showcase Your Skills: In your cover letter, don’t just list your skills—show us how you’ve used them in real situations. Talk about your experience with PPQ campaigns and regulatory guidelines. We love seeing practical examples!
Be Clear and Concise: Keep your application clear and to the point. Use straightforward language and avoid jargon unless it’s relevant to the role. We appreciate clarity and want to understand your experience without sifting through fluff.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Hyper Recruitment Solutions
✨Know Your Validation Basics
Make sure you brush up on your knowledge of process validation and the specific guidelines like FDA 2011 PV and EU GMP Annex 15. Being able to discuss these topics confidently will show that you're not just familiar with the theory but can apply it practically.
✨Prepare for PPQ Discussions
Since you'll be leading PPQ campaigns, be ready to talk about your experience with authoring protocols and defining sampling plans. Have examples from your past work where you successfully executed a PPQ and what the outcomes were.
✨Showcase Your Teamwork Skills
This role requires close collaboration with Manufacturing Operations and Technical Operations. Think of instances where you've worked in a team to solve problems or improve processes, and be prepared to share those stories during the interview.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the company's approach to new technology selection or how they maintain compliance. This shows your genuine interest in the role and helps you gauge if it's the right fit for you.