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- Tasks: Lead validation activities for new equipment and processes in a dynamic pharmaceutical environment.
- Company: Join a top-tier pharmaceutical manufacturing and packaging business in Newcastle.
- Benefits: Enjoy a collaborative culture, career growth opportunities, and potential travel experiences.
- Why this job: Make a real impact on product quality and compliance while working with cutting-edge technologies.
- Qualifications: Experience in GMP validation and a scientific or engineering degree are essential.
- Other info: Be part of a team that values innovation and excellence in the life sciences sector.
The predicted salary is between 36000 - 60000 £ per year.
Validation Lead – Pharmaceutical Manufacturing Smart4 Sciences are recruiting on behalf of a leading pharmaceutical manufacturing and packaging business for an experienced Validation Specialist to join their team at their manufacturing facility in Newcastle. This is an excellent opportunity to take ownership of validation activities across equipment, systems, processes, and facilities, playing a pivotal role in ensuring compliance with regulatory and GMP standards. Key Responsibilities Lead validation activities for the introduction of new facilities, equipment, systems, processes, products, and technologies. Generate and control validation documentation (URS, FAT/SAT, FDS, DQ, IQ, OQ, PQ, and validation reports). Maintain site validation status, ensuring all assets remain in a validated state. Prepare validation plans, protocols, and reports for equipment, systems, and software. Conduct validation studies and develop project scopes aligned with business needs. Manage the site\’s Validation Master Plan. Act as subject matter expert for validation and qualification activities. Liaise with customers for new product introductions and re-validations. Support ongoing process verification activities and ensure timely completion of CAPAs and change controls.About You Proven experience in validation within a GMP-regulated pharmaceutical or life sciences environment. Strong understanding of the full validation lifecycle and regulatory requirements. Experience with Computer Systems Validation. Confident in Microsoft Office applications. Excellent communication skills and the ability to work both independently and as part of a team. Scientific or engineering degree (or equivalent industry experience). Willingness to travel domestically and internationally as required.If you have the skills and experience to excel in this Validation Specialist role please apply today or contact Gareth Gooley on for more information
Validation Specialist employer: Smart4Sciences
Contact Detail:
Smart4Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Specialist
✨Tip Number 1
Familiarise yourself with the specific validation processes and regulatory requirements in the pharmaceutical industry. Understanding the nuances of GMP standards will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical manufacturing sector, especially those who have experience in validation roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in validation.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully led validation activities or managed complex projects. Highlighting your hands-on experience will make you stand out as a candidate who can hit the ground running.
✨Tip Number 4
Stay updated on the latest technologies and tools used in validation, particularly in Computer Systems Validation. Being knowledgeable about current software and methodologies will show that you are proactive and ready to contribute to the team effectively.
We think you need these skills to ace Validation Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a Validation Specialist. Familiarise yourself with key terms like URS, FAT/SAT, DQ, IQ, OQ, and PQ, as well as the importance of compliance with GMP standards.
Tailor Your CV: Highlight your relevant experience in validation within a GMP-regulated environment. Be specific about your previous roles and how they relate to the responsibilities listed in the job description. Use keywords from the job posting to make your CV stand out.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your expertise in validation. Mention specific projects or achievements that demonstrate your ability to lead validation activities and ensure compliance.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role in validation.
How to prepare for a job interview at Smart4Sciences
✨Know Your Validation Lifecycle
Make sure you have a solid understanding of the full validation lifecycle, especially in a GMP-regulated environment. Be prepared to discuss your experience with each phase and how it relates to the role.
✨Familiarise Yourself with Documentation
Get comfortable with the types of validation documentation mentioned in the job description, such as URS, FAT/SAT, and validation reports. You might be asked to explain how you've generated or controlled these documents in past roles.
✨Showcase Your Communication Skills
Since excellent communication is key for this role, think of examples where you've effectively liaised with teams or customers. Be ready to demonstrate how you can convey complex information clearly.
✨Prepare for Technical Questions
Expect technical questions related to validation activities and regulatory compliance. Brush up on your knowledge of Computer Systems Validation and be ready to discuss any relevant projects you've worked on.
