BD Biosciences (BDB) is a worldwide technology leader producing instrument and reagent products for customers in research and clinical markets. BDB currently enjoys a leadership position in its primary business of clinical and research flow cytometry instruments and reagents. The Rouge Project serves the research arm of BDB called Life Science Research Reagents (LSRR) based in San Diego. The Rouge Project established a Process Center for the manufacturing of stable, mature research reagent products in Tatabanya, Hungary.
QUALITY ENGINEER – VALIDATION & INSPECTION
Main Purpose of the Position
As directed by the Quality Manager, the Quality Engineer-
- Responsible for Facility Qualification, Process and Software Validation and also provide support for Equipment & Instrument Qualification activities.
- Responsible for incoming and final inspection
- Responsible for the quality processes of supplier selection, approval and assessment
Validation & Inspection:
Primary Responsibilities and Duties Validation:
- Work in a team environment to identify resources (internal, external) and develops qualification plans & schedules
- Manage the qualification schedule for the project and ensure deliverables are met and documented per the project plan and Validation master schedule
- Ensure all related qualification documentation is fulfill business & technical requirements; all strategies, plans, protocols, completion reports or any type are complete, comprehensive, technically sound and accurate
- Oversee authoring of qualification protocols, plans and reports as needed and review work of others.
- Provide analytical and strong statistical support in setting up, collecting, analyzing, documenting, and presenting evidence of the qualification work.
- Leading the incoming and final inspection team
- Ensure inspections are done according to the procedures
- Ensure fulfill inspection KPIs
- Manage inspection related issues, non-conformances and investigations
- Lead supplier and some internal quality system audits as a means of evaluating the effectiveness of the established Quality System
- Participate in supplier selection, approval and assessment process
- Requires a minimum of a Bachelor’s Degree in engineering
- A minimum of 3 years relevant experience with quality assurance and validation
- Experience with biotechnology/laboratory/medical devices/pharmaceuticals, manufacturing processes and products.
- Experience with hands-on validation planning & execution activities
- Demonstrated experience in training on validation practices.
- Applied knowledge of ISO9001 with ability to design, document and implement clear and straightforward processes and procedures
- Effective Analytical & Statistical Skills (Minitab)
- Experience with people management
- SAP QM knowledge highly preferred
- Experience with Supplier Quality Assurance process preferred
- Strong communication, organizational and project management skills.
- Fully bilingual – English – Hungarian (written and spoken)
- Quality Assurance Engineer
- Manufacturing, Production
- Quality Assurance
- Full time
- 3-5 years professional experience
Required language level:
All of these are:
- English - higher advanced/fit for negotiation
- Hungarian - higher advanced/fit for negotiation
How to apply/ contact information:
You can apply with the „jelentkezem” button underneath.