PHéNX
Developing Pragmatic CQV Solutions for the Life Sciences industry.
Our vision
PHéNX is a multidisciplinary team of solution-finders. We realize pragmatic CQV solutions for the Life Sciences/Biotech industry, ensuring compliance from the first sketch to the final handover.
Our strength lies in our solid expertise and a human-focused approach. We work with precision, total transparency, and a signature touch of rock & roll. At PHéNX, we believe operational excellence should come with a personal connection.
Our mission
GETTING YOUR PRODUCT TO THE MARKET FAST
Through our specific project strategies and by leveraging our previous project experiences we avoid the unnecessary and focus on the essential.
FIRST TIME RIGHT
Being involved in the first project stages allows us to assess the critical requirements and elements . This allows us to build a solid foundation for all the CQV/CSV next project steps.
PROVIDE FIT FOR PURPOSE SOLUTIONS
We develop creative solutions to deliver cost and time savings without sacrificing quality.
STRATEGIC PARTNERSHIP
We are a long-term accountable partner committed to deliver quality solutions and services.
We Are Looking For Not Just Anyone
What drives us?
We generate pragmatic CQV/CSV solutions for the life science/biotech industry
We don’t simply dabble in CQV and CSV, some of us have more than 25 years of experience in these fields! We’re not just about getting the job done. We infuse our projects with a blend of engagement, efficiency and …fun.
We do not make active sales. Our clients seek us out, driven by their yearning for our expertise and knowledge. When you join our ranks, you become more than just another consultant. You will be part of a dynamic project team that always goes the extra mile. We’re not here to settle for mediocrity.
We are constantly on the lookout for talented teamplayers who are passionate about making a difference.
CSV Project Manager
Are you a guru in Life Science/Biotech Commissioning, Qualification, Validation domain?
CSV Engineer
Do you have the knowledge and practical experience of the latest developments in the CSV (Computer system validation) and cGMP.
Junior CSV Engineer
Do you have the knowledge and practical experience of the latest developments in the CSV (Computer system validation) and cGMP.
CQV Engineer
Do you have the knowledge and practical experience of the latest developments in the CQV (commissioning & qualification) field and cGMP.
Junior CQV Engineer
Do you have the knowledge and practical experience of the latest developments in the CQV (commissioning & qualification) field and cGMP.
Not just anyone...
…a Guru in Life Science/Biotech Commissioning, Qualification, and Validation. Someone who excels at leading projects and teams.
If you have a strong understanding of current GMP guidelines and regulations, we want to hear from you! Join our human-sized company and be a part of our passionate team. We are always excited to meet smart and forward-thinking talents who embrace innovation with open arms. Your drive and motivation are what we value most.
So, what inspires you? What pushes you to excel in the life science industry? Share your passion and expertise, and together, let’s create a better future for healthcare.
Contact
Contact us
Guldensporenpark 120, 9820 Merelbeke
09 239 57 00 | info@phenx.be
Ready to validate our human-first approach?
> Fill out the form. We promise our response time is fully qualified, highly compliant, and 100% human. Our team of solution-providers is ready to go to work.
Cases
Cases
Takeda - OPUS ProjectUpscale of Immunoglobin Production (new Building PL6)
UCB Pharma - Genesis Project
New state-of-the-art gene therapy facility (Genesis)
Novasep - Thermo Fisher
Commissioning & qualification of new viral vector production Facility
Bilthoven Biologicals
Pandemic Readiness Program - Revamp of Building U4 – new USP/DSP vaccine DS Production Facility
GSK Vaccines
WN359 – Building WN10 Facility Improvement Program
Novasep - Thermo Fisher
Commissioning & qualification of new fill & finish CQ lab facility
Novasep - Thermo Fisher
Commissioning & qualification of new viral vector production Facility for Covid-19 Vaccine
Services & Expertise
Services
TURNKEY CQV / CSV
We can deliver complete CQV/CSV packages from design to successful handover.
We bridge the gap between requirements and operational readiness. Our multidisciplinary team is equipped to deliver a complete, ready-to-use CQV and CSV package from start to finish. We guide you through every milestone – navigating design, execution, and rigorous quality control – ensuring a seamless transition and a successful handover that meets the highest industry standards.
CQV / CSV SUPPORT
Our team supports you with the Management, preparation, execution and documentation of CQV/CSV project deliverables and protocols.
We take the heavy lifting out of commissioning, qualification, validation and compliance. Our experts provide targeted support exactly where your project needs it most. From overseeing high-level management and meticulous preparation to flawless execution and audit-ready documentation, we ensure every CQV and CSV protocol is handled with precision and operational excellence.
COMPLIANCE
Our experts can support you with meeting the regulatory requirements.
Navigating industry regulations shouldn’t be a bottleneck. Our compliance experts provide clear, pragmatic guidance to ensure your operations seamlessly meet all stringent regulatory requirements without sacrificing efficiency.
ENGINEERING SUPPORT
Our cross-functional teams can assist you with the design review and definition of your critical equipment and processes parameters.
We bring strategic depth to your technical challenges. We work alongside you to expertly support design, define and optimize, ensuring to build for operational excellence from day one.
AUDIT PREPARATION
Avoid unpleasant surprises and contact us for a pre-audit assessment.
Be proactive, not reactive. We conduct rigorous assessments to identify and resolve vulnerabilities before they become issues, ensuring you face every official audit with total readiness and confidence.
Curious how it works?
Get in touch with our team to discuss your project and discover exactly how we can turn your vision into reality.
Want to see how we did it?
Dive into our recent success stories to explore the strategies and solutions behind our work.
Fields of expertise
FACILITY
Precision starts with your environment. We ensure absolute control over your critical spaces, bringing deep expertise in validating HVAC systems, high-grade cleanroom finishes, and Environmental Monitoring Systems (EMS). From LAFs to BSCs, we guarantee your controlled environments are built for seamless compliance.
#HVAC #Cleanroom finishes #EMS #LAF #BSC #Controlled environments
PROCESS EQUIPMENT
We qualify the engines of your operation. Our team handles the validation of your core manufacturing assets, covering everything from traditional process vessels and advanced filtration systems to cutting-edge single-use technologies and bioreactors, ensuring they perform exactly as designed.
#Process vessels #Bioreactors #Filtration systems #Single use systems, …
SUPPORT EQUIPMENT
Reliable production relies on bulletproof support systems. We provide rigorous qualification for the infrastructure that keeps your lab and production floor moving. This includes autoclaves, decontamination stations, temperature-controlled storage (cold rooms, incubators, fridges/freezers), high-speed filling lines, and advanced isolators.
#Autoclaves #decontamination stations #Cold rooms #Incubators #Fridge/freezers #Filling Lines #Isolators #Lab Equipment…
CLEAN UTILITIES
We guarantee the integrity of your essential media streams, delivering fully compliant qualification for Purified Water (PW), Water for Injection (WFI), clean steam, clean compressed air, and all critical pharmaceutical gases.
#Purified Water #Water for Injection #Clean Steam #Clean compressed air #Pharmaceutical Gasses
AUTOMATED SYSTEMS
We empower your operations with seamless integration, process control, and compliance. We provide expert support for a wide range of software packages and management systems, including Process Control – SCADA & DCS Systems, Compliance & Tracking – Data Integrity & Serialization, Management Systems – WMS, EMS, AMS, LIMS, EDMS…
#AutomatedSystems #ProcessControl #IndustrialAutomation #SoftwareIntegration #SCADA #DataIntegrity #Serialization #LIMS #EDMS