At a Glance
- Tasks: Lead validation of computer systems and analytical equipment to ensure compliance and support site objectives.
- Company: Join a leading pharmaceutical company focused on quality and innovation.
- Benefits: Competitive salary, career development opportunities, and a dynamic work environment.
- Other info: Collaborative culture with opportunities for mentorship and professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring product quality and compliance.
- Qualifications: Degree in a scientific field or extensive experience in validation roles required.
The predicted salary is between 37606 - 45962 £ per year.
Job Purpose
Lead and support the validation and life-cycle maintenance of site computer systems and analytical equipment in line with regulatory requirements.
Responsibilities
- Co-ordinate and lead the validation and life cycle maintenance of site computer systems and analytical equipment as appropriate to ensure there is no break in the supply chain thus supporting Site objectives.
- Coordinate, lead, and support the compliance activity in preparation for any regulatory audit and in response to current and any subsequent legislation affecting computer systems validation, analytical equipment validation, electronic records, and electronic signatures.
This involves an approval and advisory role with respect to assessments and follow-up corrective actions.
- To provide the necessary support, as required, for all levels of corporate, customer and regulatory audits, including face to face interaction with inspectors during internal and external regulatory audits (e. g.
MHRA).
- To deliver standardised training materials on Computer Systems and Analytical Equipment validation topics and deliver training as required.
- Support standardisation of computer systems and analytical equipment validation processes, supporting roll out and adherence to these standard validation processes to deliver consistency and agility with cost benefits.
- To understand the impact on ways of working relevant to Computer Systems and Analytical Equipment validation as required through changes in legislation.
- Support the delivery of innovative strategies that are implemented by co-ordinating appropriate validation standards without adding significant cost to the business ensuring continuous improvement and long-term viability.
- Act as Subject Matter Expert (SME) for computer system and analytical equipment regulations.
- Support the development and use of systems within the wider networks and maintain links with Central IT, Quality, Shared Services, and other sites.
About you
Essential
Degree in a relevant scientific/technical discipline
(e. g. Chemistry, Biology, Engineering, Computer Science) or extensive industry experience in a comparable field.
Minimum 5 years’ experience in validation/quality roles within GMP pharmaceutical or closely related industry.
- Strong, demonstrable experience of computerised systems validation , spreadsheet validation and laboratory equipment qualification.
- Solid working knowledge of
- GAMP 5 ,
21 CFR Part 11 and related data integrity expectations, with practical application on site.
- Able to write, review and challenge validation documents, and explain complex validation concepts clearly to less experienced colleagues.
- Proven ability to work cross-functionally, influence stakeholders and represent validation during audits/inspections.
Desirable
- Experience in
API manufacturing or primary chemical/pharmaceutical operations.
- Experience leading or significantly contributing to CSV / data integrity programmes at site or network level.
- Prior experience mentoring or training in validation topics.
Validation and Quality Engineer in Irvine employer: Booth Welsh
At Booth Welsh, we pride ourselves on fostering a culture of continuous improvement and collaboration, making us an exceptional employer for a Supplier Quality Engineer. Our commitment to employee development is reflected in our competitive benefits package, including 33 days of holiday, ongoing professional development opportunities, and a supportive work environment where engineers are empowered to take ownership and drive quality improvements. Join us in a technically demanding engineering landscape where your contributions will have a meaningful impact on supplier performance and customer satisfaction.
StudySmarter Expert Advice🤫
We think this is how you could land Validation and Quality Engineer in Irvine
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Booth Welsh. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Booth Welsh.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Booth Welsh. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Booth Welsh is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Validation and Quality Engineer in Irvine
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Booth Welsh!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Booth Welsh that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Booth Welsh!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Booth Welsh, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Booth Welsh
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Booth Welsh that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Booth Welsh’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
