At Univercells Technologies, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all!! This job is the perfect opportunity to contribute to our mission and be impactful.
Based in Nivelles (Belgium), reporting to the Head of Quality and Validation.
As Quality Assurance Specialist for equipment development, you will act as QA stakeholder for equipment development projects. You will be part of project team(s) responsible to develop and qualify the equipment. You will 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 first delivered products.
- Act as QA stakeholder in project team(s)
- Together with the validation department, support the implementation of best practices in the project
- Review Design reports, DFMEA, validation plan, FAT/SAT & IQOQ protocols, software validation strategy…
- Support specifications definition (components as well as URS/FS).
- With QA and validation team, support implementation of knowledge management
- Identify & escalate quality risks
- MSc in Engineering fields (Electricity, Electro-mechanics, Mechanics, Automation…) or equivalent by experience
- Minimum 8 years combined experience in Pharma/Biotech space
- Experience in equipment and software validation
- Strong knowledge of GxP
- Good influencing skills
- Strong in communication skills and team player
- Ability to work in fast paced environments and to combine strategic and tactical actions
- Fluent English and French
We offer a long-term contract, a competitive salary package (health insurance, pension plan, meal vouchers…) and the possibility of evolution in an international, dynamic and fast-growing company.
Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Apply now !