ALTEN Belgium is a leading consultancy company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.
In our open and adaptable organisation, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.
All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.
We are currently looking for Commissioning & Qualification SME at one of our clients.
Help ensure that critical equipment and utilities are qualified, compliant, and supporting reliable manufacturing operations.
Main responsibilities
C&Q Activities
* Ensure equipment and utilities remain qualified and compliant.
* Coordinate assigned qualification activities and act as Technical Owner.
* Own and deliver accurate Equipment Qualification files.
Project Support & Documentation
* Perform assessments for projects, changes, deviations, and investigations.
* Participate in project meetings and keep updates current.
* Communicate test needs, planning, and resource requirements with partner departments.
Collaboration & Guidance
* Provide qualification engineers with relevant information, support, and technical guidance.
* Review and approve qualification documents in KNEAT (URS, SRS, DQ, QP, IQ, OQ, PQ, etc.).
* Review executed qualification tests and ensure documentation quality.
* Act as qualification engineer/technical writer when needed.
* Work closely with QA to obtain timely file approvals.
Quality, Compliance & Improvement
* Maintain compliance with GMP and current regulatory expectations.
* Identify gaps in procedures, qualification files, or systems, and escalate when necessary.
* Support internal improvement initiatives and Kaizen activities.
* Assist with inspections, training, and maintaining Validation Master Plans.
* Initiate and follow up non‑conformances and corrections.
Your profile
* 5 years of relevant pharmaceutical experience (GMP environment) in a qualified setting
* Technical knowledge of aseptic/sterile equipment/processes required
* Ideally, technical-scientific training
* Dutch language skills are a plus
* Knowledge of KNEAT (paperless validation system) is a plus
What ALTEN has to offer
* A permanent contract
* A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances)
* The possibility to join a great team and be part of the success story of an international group
Apply now and be a part of our amazing journey. We believe in growing together!
We are looking forward to getting to know you and your ambitions!