Publiée le 18 juin
Mission du poste
We are looking for a Qualification Engineer (HVAC, Clean Rooms & Clean Utilities) to support CQV activities within a biopharmaceutical project environment. The role focuses on ensuring the compliant and timely qualification of critical systems, working closely with cross-functional teams across engineering, quality, and operations.
Apply fast, check the full description by scrolling below to find out the full requirements for this role.
ABOUT THE POSITION:
- Execute qualification and validation activities (IQ/OQ) for assigned systems (HVAC, clean utilities, process equipment)
- Prepare and manage validation documentation (URS, Impact Assessments, protocols) in Kneat
- Perform field verification (“as-built”) activities based on P&IDs
- Review vendor and commissioning documentation (welding, passivation, IO checks)
- Ensure compliance with GMP regulations (EU Annex 15, 21 CFR, internal standards)
- Generate and approve qualification reports following test execution
- Coordinate with cross-functional teams (CQV, engineering, automation, quality, construction)
- Track progress, resolve technical issues, and ensure on-time delivery of qualification milestones
ABOUT YOU:
- Experience in pharmaceutical/biotech qualification (CQV), ideally on HVAC, cleanrooms & utilities
- Good knowledge of GMP regulations (EU & US) and cleanroom standards (ISO 14644, Annex 1)
- Fluent in Dutch and English
- Understanding of process and clean utility systems design
- Strong organization, communication, and quality & safety mindset
ABOUT US:
Vulcain Engineering is a group specialized in the energy sector that supports companies active in Renewable & Nuclear Energy, Gas & Infrastructure through our Study Offices and Consultancy services. Vulcain Engineering Group is positioned as a transformation partner thanks to its ultra-specialization in strategic sectors which positively impact the transformation of our society and supports its clients in their transformation towards more sustainable and responsible models. Vulcain supports its clients throughout the entire life cycle of their projects, from design to commissioning, by integrating constructability and safety requirements right from the design phase.
In Belgium, our activities focus on consultancy services, delivering expertise in three main areas:
- Energy/Infrastructure
- Gas Renewables & Processes
- Life Sciences
With headquarters based in Brussels, and clients spread all over the country, we address key projects in the Belgian industry, offering our consultants the opportunity to work on challenging topics and discover different areas during their time at Vulcain.
Why would you apply? xphnsxz
- An annual gross salary ranging from 52 000€ to 58 000€ paid over 13,92 months and advantages such as a company car (and fuel card), representation fees, insurances, meal vouchers, eco cheques, a sectorial bonus (the salary indicated corresponds to the level of experience mentioned in the job description. For any other level of experience, the annual salary may vary accordingly)
- A tailored career path within the company : opportunities to discover different business units, training, follow-up from your business manager, and a development evaluation every year
- A human-based company with slightly more than 120 consultants and synergies between the different business units