At a Glance
- Tasks: Lead validation and qualification activities in a dynamic manufacturing environment.
- Company: Join a leading company in the pharmaceutical and life sciences sector.
- Benefits: Competitive salary, career growth, and a chance to make an impact.
- Other info: Collaborative culture with opportunities for professional development.
- Why this job: Be a key player in ensuring compliance and quality in innovative processes.
- Qualifications: Degree in Science, Engineering, or Pharmacy with GMP experience preferred.
The predicted salary is between 55000 - 65000 £ per year.
A key opportunity has arisen in our Quality team, we are looking for a Validation and Qualification Manager. The role acts as the technical subject matter expert for validation and qualification activities associated with facilities, utilities, manufacturing equipment, processes, cleaning systems and analytical methods.
The Validation Lead ensures that all validation activities are conducted in accordance with GMP, MHRA requirements, EU GMP Annex 15, ICH guidance and internal quality standards, maintaining the validated state throughout the lifecycle of GMP systems and processes. The role also provides technical leadership during regulatory inspections, customer audits and certification assessments.
Key Responsibilities- Accountable for establishing, maintaining and continuously improving the site Validation Master Plan and associated validation framework across both the Sodium Bicarbonate and British Salt operations.
- Responsible for ensuring validation standards, procedures, templates and governance systems remain inspection-ready and support a compliant, risk-based approach to validation across the business.
- Responsible for ensuring that facilities, utilities and equipment remain in a qualified state throughout their operational lifecycle. This includes oversight and approval of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities, ensuring all qualification work is appropriately documented, scientifically justified and compliant with regulatory requirements.
- Provides technical leadership and coaching across the organisation to promote a strong validation and GMP compliance culture working with internal stakeholders to improve validation practices, implement risk-based approaches and identify opportunities to strengthen compliance and operational effectiveness.
We want someone who can hit the ground running with our Validation programme across TCE. The ideal candidate will be a proven Validation and Qualification professional preferably with a degree in Science, Engineering, Pharmacy or related discipline and will have the following experience:
- GMP experience within pharmaceutical, API, chemical or life sciences manufacturing would be great with a strong understanding of Annex 15, ICH Q7 to Q10.
- Experienced in leading DQ, IQ, OQ, PQ, process and cleaning validation.
- Supported regulatory inspections as well as MHRA inspections.
- Audit qualifications would be advantageous.
- Proven experience of managing stakeholders through a validation programme with strong influencing skills to create a proactive approach.
- Worked collaboratively in previous roles with Production, Engineering and Quality functions to support process improvements while maintaining regulatory compliance.
Validation and Qualification Manager in Warrington employer: Morson Group
As a Senior CATIA Design Engineer, you will join a forward-thinking company that values innovation and collaboration in the aerospace sector. With a hybrid working model that promotes work-life balance and a culture of mentorship, you will have ample opportunities for professional growth while contributing to cutting-edge landing gear systems for both civil and military aircraft. Our commitment to employee development and the use of advanced technology ensures that you will thrive in a dynamic environment that prioritises excellence and teamwork.
StudySmarter Expert Advice🤫
We think this is how you could land Validation and Qualification Manager in Warrington
✨Join Engineering Meetups!
Get yourself along to local engineering meetups or tech conferences. These are great places to connect with like-minded folks and industry leaders who might just have a lead on that full-time Validation and Qualification Manager role you’re after at Morson Group.
✨Show Off Your Projects!
Don’t be shy about showcasing your engineering projects. Whether it’s a funky app, a mechanical design, or a complex algorithm, having a solid portfolio on platforms like GitHub can really make you stand out. Plus, it gives potential employers at Morson Group a taste of what you can bring to the table!
✨Engage with Online Communities
Dive into engineering forums and online communities, like Reddit or specific engineering Discord channels. Sharing your insights, asking questions, and being active can help you build connections that might lead to job opportunities at Morson Group.
✨Apply Through Company Websites
When you spot a role like Validation and Qualification Manager at Morson Group, apply directly through their website. Often, this can show your genuine interest in the company and you might just get noticed quicker than via typical job boards.
We think you need these skills to ace Validation and Qualification Manager in Warrington
Some tips for your application 🫡
Showcase Your Technical Expertise:When applying for an engineering role like Validation and Qualification Manager, it’s essential to highlight your technical skills. Include any relevant software or tools you're proficient in on your CV—think CAD software, simulation tools, or programming languages. Don't skimp on any engineering projects you've worked on that demonstrate your ability to solve complex problems.
Focus on Results and Impact:In the engineering world, we love numbers and real-world impact. Quantify your achievements wherever possible—like reducing costs by a certain percentage, improving efficiency, or successfully completing a project ahead of schedule. This gives your future employers at Morson Group a clear picture of the value you can bring.
Craft a Compelling Cover Letter:Use your cover letter to express your passion for engineering and explain why you’re drawn to Morson Group specifically. Share what aspects of their work excite you and how your values align with theirs. This is your chance to show a bit of personality while keeping it professional!
Include Relevant Certifications:If you have any engineering certifications, especially ones that are recognised in your field, make sure to feature them prominently on your CV. They demonstrate not just your knowledge, but also your commitment to professional development, which is something we at StudySmarter value highly.
How to prepare for a job interview at Morson Group
✨Brush Up on Core Engineering Principles
Before heading into the interview with Morson Group, make sure you're solid on the fundamental engineering principles relevant to the role. Be ready to discuss concepts such as thermodynamics, fluid mechanics, or structural analysis, depending on the specifics mentioned in the job description. Don’t skip any hands-on projects or coursework; these can be excellent talking points!
✨Show Off Your Problem-Solving Skills
Expect technical questions or case studies during your interview—after all, engineering is all about solving problems! Prepare a few examples of how you've tackled engineering challenges in the past, whether at university or in any practical experience. Practising with mock technical interviews can really help you articulate your thought process and solutions.
✨Relate Your Experience to the Role
In a full-time role, employers like Morson Group want to see that you can adapt and grow within their team. Be ready to discuss how your previous internships, projects, or studies relate directly to the work you'll be doing. Highlight specific experiences that showcase your collaborative skills and how you've successfully worked within a team environment.
✨Know Your Tools and Software
Most engineering roles require familiarity with specific tools and software. Prepare to talk about your proficiency with programmes like AutoCAD, MATLAB, or SolidWorks if they’re relevant to the role. Even better, have examples of projects where you’ve used these tools, as it'll demonstrate your hands-on experience and readiness for the job.