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- Tasks: Join us as a CQV Engineer, focusing on Clean Utilities in biopharmaceutical projects.
- Company: Be part of a leading pharmaceutical manufacturing team in North East England.
- Benefits: Enjoy a long-term contract with potential for 2-3 years and competitive pay.
- Why this job: Work on impactful clean utility systems and gain valuable industry experience.
- Qualifications: Experience in CQV and clean utility systems is preferred; WFI knowledge is a plus.
- Other info: This role is outside IR35, offering flexibility and independence.
The predicted salary is between 36000 - 60000 £ per year.
We are seeking an experienced CQV Engineer with specialized expertise in Clean Utilities to support a pharmaceutical project for a long term contract. The Engineer will be working on the following systems: Purified Water, Clean Steam, Process Gases (e.g., Nitrogen, Compressed Air) and WFI. Experience with WFI systems is considered a strong advantage, but not a strict requirement.
Key Responsibilities:
- Develop and execute CQV lifecycle documentation (DQ, IQ, OQ, PQ) for clean utility systems.
- Oversee and support commissioning activities, including loop checks, functional testing, FAT/SAT execution, and field verification.
- Review engineering and design documents (P&IDs, URS, equipment datasheets) to ensure alignment with regulatory and operational requirements.
- Coordinate with vendors, contractors, and internal teams to facilitate the timely and compliant delivery of clean utility systems.
- Perform risk assessments and define validation strategies based on system impact and criticality.
- Manage and resolve deviations, discrepancies, and change controls related to clean utility equipment and processes.
- Ensure all documentation is accurate, complete, and audit-ready.
This is an initial 12 month contract, but the project scope is for 2-3 years, so the role offers excellent longevity.
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CQV Engineer
✨Tip Number 1
Network with professionals in the biopharmaceutical industry, especially those who have experience with Clean Utilities. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends in CQV engineering.
✨Tip Number 2
Familiarise yourself with the specific clean utility systems mentioned in the job description, such as Purified Water and Clean Steam. Having a solid understanding of these systems will help you stand out during interviews.
✨Tip Number 3
Prepare to discuss your previous experience with CQV lifecycle documentation and commissioning activities. Be ready to provide examples of how you've successfully managed similar projects in the past.
✨Tip Number 4
Research StudySmarter and our role in the biopharmaceutical sector. Understanding our company values and mission can help you tailor your approach and demonstrate your enthusiasm for joining our team.
We think you need these skills to ace CQV Engineer
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a CQV Engineer in Clean Utilities. Familiarise yourself with the specific systems mentioned in the job description, such as Purified Water and Clean Steam.
Tailor Your CV: Highlight your relevant experience in CQV processes, especially with clean utility systems. Make sure to include any specific projects or roles that demonstrate your expertise in DQ, IQ, OQ, and PQ documentation.
Craft a Strong Cover Letter: Write a cover letter that directly addresses the key responsibilities outlined in the job description. Emphasise your experience with commissioning activities and your ability to manage deviations and discrepancies.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. Ensure that all information is clear, concise, and professional to make a great first impression.
How to prepare for a job interview at X4 Life Sciences
✨Know Your Clean Utilities
Make sure you brush up on your knowledge of clean utility systems, especially Purified Water and Clean Steam. Be prepared to discuss your experience with these systems and any relevant projects you've worked on.
✨Familiarise Yourself with CQV Documentation
Understand the CQV lifecycle documentation process, including DQ, IQ, OQ, and PQ. Be ready to explain how you've developed or executed these documents in past roles.
✨Highlight Your Team Coordination Skills
Since the role involves coordinating with vendors and internal teams, think of examples where you've successfully collaborated with others. Share specific instances that demonstrate your ability to manage relationships and ensure project compliance.
✨Prepare for Technical Questions
Expect technical questions related to risk assessments and validation strategies. Review common scenarios and be ready to discuss how you would approach managing deviations and discrepancies in clean utility processes.
