Donaldson is committed to solving the world’s most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities.
Univercells Technologies by Donaldson :
Univercells Technologies, located in Nivelles – Belgium, is the latest addition to a growing list of initiatives within the Life Sciences division of Donaldson.
Univercells Technologies manufacture and developpe bioreactors, manifolds and controllers for pharmaceutical industry and laboratory.
Mission :
You will be part of a small and polyvalent quality team managing different quality processes.
As Quality engineer facilities and equipment, you will be QA point of contact for equipment and facilities matters.
Regarding operational capability, you will be responsible to perform oversight of the maintenance and facility processes such as calibration, maintenance shutdown management, PEST control etc. As SPOC for these topics you will have to manage deviations, change control and review of maintenance forms with the team.
Regarding development activities, you will also act s Quality Assurance SPOC for equipment design, qualification and installation by performing an oversight of the whole equipment lifecycle from development to release and use at customer site. You’ll be part of project team(s) responsible to develop and qualify the equipment. You’ll be responsible to ensure quality by design is implemented as well as best practices for equipment development and qualification. You will also support FAT/SAT IQOQ of the delivered products. You’ll be part post sales activities (investigations, improvement, upgrade) as well.
Key Responsibilities:
-Act as the QA for the maintenance & facility team (oversight for the routine activities, calibration, event/deviations/CAPA)
- Act as the QA Validation, for the qualification of new equipment (“small equipment” like sealing machine to “big equipment” like waterloop, dryer etc.)
- Act as QA stakeholder in project team(s)
- Act as QA stakeholder with manufacturing, service and maintenance teams
- Review Design reports, DFMEA, validation plan, FAT/SAT & IQOQ protocols, software validation strategy…
- Support specifications definition (components as well as URS/FS).
- Identify & escalate quality risks
- Quality point of contact for all related activities: deviations, change control, CAPA, documents review, complaints….
Qualifications :
-Minimum of a master’s degree in engineering or science field
- At least 5 years of experience in maintenance, equipment qualification, software validation
- Knowledge/experience regarding quality system (non-conformity, investigation, GMP, ..), not especially as quality assurance role.
-Excellent oral and writing skills in English and French
-Driven, rigorous and organized
-Hands-on and eager to embrace the unknown
- Self-learner and autonomous
- Flexibility in the tasks, and change of scope
- Good communication and stakeholder management skills.
- Ability to work in fast-paced environments.
- Team spirit
OFFER :
We offer a long-term contract, a competitive salary package (health insurance, company car, pension plan, meal vouchers…) and the possibility of evolution in an international, dynamic and fast-growing company.