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- Tasks: Lead validation of computer systems and ensure compliance with regulatory standards.
- Company: Join Bespak, a leading pharmaceutical manufacturer focused on respiratory products.
- Benefits: Enjoy 25 days holiday, generous pension, private medical insurance, and more.
- Other info: Flexible working arrangements and a commitment to inclusivity make this a great workplace.
- Why this job: Make a real impact in a growing company dedicated to patient health.
- Qualifications: Experience in Computer System Validation and strong problem-solving skills required.
The predicted salary is between 40000 - 47000 £ per year.
Bespak are looking for a Principal Validation Specialist – CSV. This is a permanent position for the Holmes Chapel site, CW4 8BE. The salary for this role is £47,000 - £55,400. Other benefits you will receive are 25 days annual leave plus bank holidays, discretionary annual bonus, generous 10% pension contribution, onsite free parking, and medical / dental / health / life assurance.
Working Pattern – Monday to Friday usual working times of 8:30am to 5:00pm with an 8:30 am to 3:45pm finish on a Friday.
The Principal Validation Specialist – CSV will provide subject matter expertise for the qualification and validation of GxP computerised systems (CSV) across the Bespak Holmes Chapel site, ensuring compliance with regulatory requirements and data integrity (DI) principles. The role leads and supports validation lifecycle activities, including periodic reviews, user access reviews, and DI risk assessments, while authoring, reviewing, and approving CSV documentation. Working closely with system owners and project teams, the role provides technical guidance and coordinates qualification and validation activities to ensure compliant implementation and ongoing system control.
As a Principal Validation Specialist – CSV your role will include:
- Provide technical leadership for Computer System Validation and Data Integrity across site systems and projects.
- Define and implement risk-based validation strategies aligned with GxP and regulatory guidance.
- Support new system implementations, upgrades, and digital initiatives, ensuring compliant validation approaches from design through to lifecycle management.
- Act as the site CSV subject matter expert, advising system owners, engineers, and project teams.
- Lead or support investigations, deviations, and technical problem solving related to validated systems.
- Ensure systems remain validated, controlled, and inspection-ready through periodic reviews, risk assessments, and lifecycle management.
What you will bring:
- Proven experience in Computer System Validation within a GMP-regulated environment.
- Strong understanding of Data Integrity principles and regulatory expectations (e.g., GxP, ALCOA+).
- Experience delivering validation strategies for complex systems or projects.
- Ability to work cross-functionally with technical and operational teams.
- Strong documentation, analytical, and problem-solving skills.
Why join Bespak:
- Take ownership of CSV strategy and validation lifecycle management.
- Work on complex regulated systems and cross-functional projects.
- Influence site-wide compliance, digital systems, and continuous improvement initiatives.
- Be part of a high-performing technical team supporting advanced manufacturing operations.
Principal Validation Specialist - CSV beneficial key skills and experience:
- Degree or level 6 equivalent in scientific/engineering discipline with five or more years relevant pharma validation experience.
- Time and project management skills with the ability to multitask.
- Proven interpersonal skills required and the desire to motivate, inspire and develop colleagues.
- High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction.
- Experience and expertise in communication exchanges with customers, presentation at meetings and fronting during audits and regulatory inspections.
- Excellent oral and written communication skills and listening skills.
- Strong problem-solving skills.
- Experience in a growth-oriented, cGMP contract manufacturing organization is preferred.
Benefits:
- 25 days annual holiday + bank holidays + Buy/Sell Scheme.
- A generous employer pension contribution.
- Private medical insurance.
- Private dental Insurance.
- Permanent Health Insurance.
- Group life assurance.
- Free will writing service.
- Active well-being programme.
- Recognition awards.
- Free Parking.
Holmes Chapel is a beautiful village in Cheshire with excellent transport links via its railway station on the Crewe-Manchester Line, proximity to the motorway network and Manchester Airport. The National Parks of the Peak District, Lake District and Eryri (Snowdonia) are within easy reach. The village has a population of nearly 7,000 and offers various amenities, including supermarkets, shops, restaurants, schools, and a GP practice.
As an ethical employer we align our BZero sustainability initiative to the SBTI certification which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485.
We are flexible. We understand that there is a life outside of work, so we aim to support you in attaining a happy work/life balance. To cater for employees’ individual circumstances, and where possible, we agree flexible working arrangements.
We value our inclusivity as we believe diversity should be embraced and celebrated. We live and work by these values and that’s what makes our company a great place to work.
We are proud to be a disability positive employer. We will support you throughout the recruitment process with any adjustments you require therefore please contact the Recruitment Team if you require support.
By applying to this role, you are giving consent to Bespak Limited to process your personal data for employment/recruitment purposes only. All personal and sensitive data processed to Bespak is protected under GDPR regulations.
Principal Validation Specialist - CSV employer: Bespak
Contact Detail:
Bespak Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Validation Specialist - CSV
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their values and how they align with yours. We want you to walk in feeling confident and ready to show them why you’re the perfect fit for the Principal Validation Specialist position.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or family to get comfortable with common questions. We suggest focusing on your experience with GxP compliance and data integrity principles, as these will be key topics during your interview.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way in showing your enthusiasm for the role. We believe this small gesture can set you apart from other candidates and keep you fresh in their minds.
We think you need these skills to ace Principal Validation Specialist - CSV
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principal Validation Specialist role. Highlight your experience in Computer System Validation and any relevant projects you've worked on. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a perfect fit. We love seeing enthusiasm and a personal touch, so let your personality come through.
Showcase Your Problem-Solving Skills: In your application, don't forget to mention specific examples of how you've tackled challenges in previous roles. We value strong problem-solving skills, especially in a regulated environment like ours, so make sure to highlight those experiences!
Apply Through Our Website: Once you're ready, head over to our website to submit your application. It's the best way to ensure your application gets to us directly. Plus, you'll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Bespak
✨Know Your CSV Inside Out
Make sure you brush up on your knowledge of Computer System Validation (CSV) and Data Integrity principles. Be prepared to discuss specific regulatory requirements and how they apply to the role. This will show that you’re not just familiar with the concepts, but that you can also apply them in a practical setting.
✨Showcase Your Problem-Solving Skills
Prepare examples of past challenges you've faced in validation processes and how you resolved them. Highlight your analytical skills and ability to work cross-functionally. This will demonstrate your capability to lead investigations and support technical problem-solving effectively.
✨Understand the Company Culture
Familiarise yourself with Bespak’s core values: Customer Focused, Respectful, Collaborative, and Agile. Think of ways you can embody these values in your responses during the interview. This will help you connect with the interviewers and show that you’re a good fit for their team.
✨Prepare Questions for Them
Have a few thoughtful questions ready to ask at the end of your interview. Inquire about their current projects or how they implement their sustainability initiatives. This shows your genuine interest in the company and the role, and it gives you a chance to assess if it’s the right fit for you too.