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- Tasks: Lead CQV activities for HVAC systems and utilities in a pharmaceutical environment.
- Company: Join a dynamic engineering consultancy focused on patient-centric solutions.
- Benefits: Generous leave, health coverage, and professional development opportunities.
- Other info: Inclusive culture that celebrates innovation and diverse perspectives.
- Why this job: Make a real impact in the pharmaceutical industry while advancing your career.
- Qualifications: Bachelor's degree in Engineering and ~5 years of relevant experience.
The predicted salary is between 45000 - 55000 £ per year.
About No deviation, we are dedicated to delivering patient‑centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation. We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview: We are seeking a Qualification Engineer to lead the commissioning, qualification, and validation (CQV) activities for HVAC systems, cleanrooms, and critical utilities within a GMP‑regulated pharmaceutical environment. The role will focus on end‑to‑end qualification lifecycle execution, ensuring compliance with EU GMP Annex 15, ASTM E2500, and industry best practices.
Key Responsibilities
- Commissioning & Qualification Execution: Support CQV lifecycle activities for HVAC, cleanrooms, and utilities systems (e.g., PW, WFI, Clean Steam, compressed air). Execute IQ, OQ, and PQ protocols for facilities and utilities systems. Participate in commissioning activities including system walkdowns and punch listing. Perform functional testing and verification of system performance.
- Documentation & Protocol Development: Develop and/or execute qualification documents: URS (review), SIA (System Impact Assessment), Risk Assessments / Criticality Assessments. DQ, IQ, OQ, PQ protocols and reports. Ensure traceability through RTM (Requirements Traceability Matrix).
- HVAC & Cleanroom Qualification: Perform or support airflow visualization (smoke studies), HEPA filter integrity testing (PAO/DOP), air velocity and air change rate verification, temperature and humidity mapping, room pressure cascade verification.
- Utilities Qualification: Support qualification of water systems (PW/WFI loops), clean steam systems, compressed gases (CDA, nitrogen, oxygen). Execute sampling and testing activities in collaboration with QA/QC teams.
- Stakeholder Coordination: Work closely with Engineering / Facilities teams, vendors and system integrators, QA/Validation teams. Support FAT/SAT activities where required.
- GMP Compliance & Quality: Ensure all activities comply with cGMP requirements and data integrity (ALCOA+) principles. Support deviations, CAPA, and change control activities.
Required Qualifications
- Education: Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical or related discipline).
- Experience: ~5 years of relevant CQV/Validation experience in pharmaceutical or biotech industry. Hands‑on experience in HVAC / cleanroom qualification and utilities systems qualification.
- Technical Skills: Familiar with EU GMP Annex 15, ASTM E2500, ISPE Baseline Guides (Volume 5 – Commissioning & Qualification). Strong understanding of HVAC systems and cleanroom classifications (Grade A–D) and utilities systems design and operation.
- Soft Skills: Strong documentation and technical writing skills, good stakeholder management and communication skills, ability to work independently and in cross‑functional teams.
Why join us?
- Generous Leave Policy.
- Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
- Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
- Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
- Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply? Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team! Please submit your resume, outlining your qualifications and experience relevant to the role, here.
Qualification Engineer (HVAC / Facilities / Utilities) employer: Consortium for Clinical Research and Innovation Singapore
Contact Detail:
Consortium for Clinical Research and Innovation Singapore Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualification Engineer (HVAC / Facilities / Utilities)
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Understand their values, like empathy and integrity, so you can show how you fit into their culture. Tailor your answers to reflect their mission!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable with common questions. The more you practice, the more confident you'll feel when it’s time to shine.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about joining our team.
We think you need these skills to ace Qualification Engineer (HVAC / Facilities / Utilities)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Qualification Engineer role. Highlight your relevant experience in HVAC, cleanroom qualification, and utilities systems. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to express your passion for the pharmaceutical industry and how you embody our values of Empathy, Integrity, and Transparency. Let us know why you're excited about this opportunity!
Showcase Your Technical Skills: Don’t forget to mention your familiarity with EU GMP Annex 15 and ASTM E2500. We’re looking for someone who knows their stuff, so be sure to highlight any hands-on experience you have in CQV activities.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Consortium for Clinical Research and Innovation Singapore
✨Know Your CQV Basics
Make sure you brush up on the fundamentals of Commissioning, Qualification, and Validation (CQV) before your interview. Familiarise yourself with EU GMP Annex 15 and ASTM E2500, as these are crucial for the role. Being able to discuss these topics confidently will show that you're serious about the position.
✨Showcase Your Hands-On Experience
Prepare to share specific examples from your past work, especially related to HVAC systems and cleanroom qualifications. Highlight any hands-on experience you've had with IQ, OQ, and PQ protocols, as well as any functional testing you've performed. Real-world examples will help you stand out.
✨Emphasise Soft Skills
While technical skills are important, don't forget to highlight your soft skills too! Communication and stakeholder management are key in this role. Be ready to discuss how you've successfully collaborated with cross-functional teams or managed vendor relationships in previous positions.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions prepared. Inquire about the company's approach to continuous development or how they foster collaboration within teams. This shows your genuine interest in their culture and values, aligning with their emphasis on empathy, integrity, and transparency.