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- Tasks: Lead the validation and operation of clean utility systems in a dynamic pharmaceutical environment.
- Company: Join Walker Cole International, a key player in the pharmaceutical manufacturing sector.
- Benefits: Enjoy a permanent role with opportunities for continuous improvement and professional growth.
- Why this job: Be part of a team that ensures compliance and drives sustainability in healthcare.
- Qualifications: Degree in Engineering and experience in GMP-regulated environments required.
- Other info: Act as a subject matter expert during audits and collaborate with diverse teams.
The predicted salary is between 36000 - 60000 £ per year.
Walker Cole International is currently supporting a leading pharmaceutical manufacturer in the recruitment of a QA Validation Engineer to join their team on a permanent basis. The QA Validation Engineer will be responsible for the ongoing operation, validation, and continuous improvement of clean utility systems including Purified Water (PW), Water for Injection (WFI), Clean Steam, Compressed Air, and Process Gases, ensuring compliance with GMP and regulatory standards. What the QA Validation Engineer will be doing: * Leading the operation and validation of clean utility systems, ensuring reliability and compliance. * Managing deviations, CAPAs, change controls, and documentation in line with GMP and regulatory standards. * Acting as a subject matter expert (SME) during audits and inspections. * Driving continuous improvement projects to enhance system performance and sustainability. * Collaborating with cross-functional teams to support production and facility operations. What the ideal QA Validation Engineer will have: * Degree in Mechanical, Chemical, or Process Engineering (or related field). * Relevant experience working with clean utilities or validation in a GMP-regulated pharmaceutical or biotech environment. * Strong knowledge of clean utility systems and relevant standards (e.g., EU GMP Annex 1, USP, ISPE). * Experience with validation protocols, change control, and deviation investigations. QA Validation Engineer | Clean Utilities | Water for Injection | Purified Water | Clean Steam | GMP | Pharmaceutical Manufacturing | Validation Engineer | Process Utilities | Pharmaceutical Engineer | CAPA | Deviation Management | Change Control | Quality Assurance | Compliance | Regulatory | ISPE | EU GMP Annex 1 | Utilities Validation
QA Validation Engineer employer: WALKER COLE INTERNATIONAL LTD
Contact Detail:
WALKER COLE INTERNATIONAL LTD Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Validation Engineer
✨Tip Number 1
Familiarise yourself with the specific clean utility systems mentioned in the job description, such as Purified Water and Clean Steam. Understanding their operation and validation processes will help you demonstrate your expertise during interviews.
✨Tip Number 2
Brush up on your knowledge of GMP regulations and standards like EU GMP Annex 1 and USP. Being able to discuss these in detail will show that you're serious about compliance and quality assurance.
✨Tip Number 3
Prepare examples of past experiences where you've managed deviations or CAPAs. Highlighting your problem-solving skills in real-world scenarios can set you apart from other candidates.
✨Tip Number 4
Network with professionals in the pharmaceutical industry, especially those who work with clean utilities. Engaging with them can provide insights into the role and may even lead to referrals for the position.
We think you need these skills to ace QA Validation Engineer
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a QA Validation Engineer. Familiarise yourself with clean utility systems and the specific requirements mentioned in the job description.
Tailor Your CV: Highlight your relevant experience in clean utilities and validation within a GMP-regulated environment. Use specific examples that demonstrate your knowledge of standards like EU GMP Annex 1 and your involvement in continuous improvement projects.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and validation. Mention your degree and any relevant certifications, and explain how your skills align with the company's needs and values.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a QA Validation Engineer.
How to prepare for a job interview at WALKER COLE INTERNATIONAL LTD
✨Know Your Clean Utility Systems
Make sure you have a solid understanding of clean utility systems like Purified Water and Clean Steam. Be prepared to discuss your experience with these systems and how they relate to GMP compliance.
✨Familiarise Yourself with Regulatory Standards
Brush up on relevant standards such as EU GMP Annex 1 and USP. Being able to reference these during your interview will demonstrate your knowledge and commitment to quality assurance.
✨Prepare for Scenario-Based Questions
Expect questions about managing deviations, CAPAs, and change controls. Think of specific examples from your past experience where you successfully navigated these challenges.
✨Showcase Your Continuous Improvement Mindset
Be ready to discuss any continuous improvement projects you've led or contributed to. Highlight how these initiatives enhanced system performance and sustainability in your previous roles.
