Beschreibung
Task:Function:
The Validation Technician prepares and performs validation activities in order to ensure that the client's facilities and production systems are validated according to external regulatory and internal standards.
Responsibilities:
The Validation Technician is responsible to ensure that the validation team tasks are delivered with the right quality on the right time which includes:
- Performing FAT, SAT, commissioning, Installation, Operational and Performance Qualifications of:
- Production process, Process equipment, Utilities, Automation.
- Performing technical risk assessments (e. g. Process-FMEAs)
- Providing input for regulatory submissions with regard to validation studies.
- Providing base business validation support in solving events, NC's and CAPA's.
- Participation in preparation of audits and inspections.
Requirements (Must have):
- BS in Engineering (or science) or equivalent
- Relevant further education in one of the following fields: quality, validation or technical risk management
- At least 2 years hands-on experience in validation within Medtech or pharmaceutical industry
- good English (B2) and fluent German spoken and written
Further Experince in:
- CAPA
- CSV
- Equipment Validation Experiences
- ISO Regulations *
- NCR( NON CONFORMANCE RECORD)
- PFMEA
- Process Validation Experiences
- QM (Quality Management)
Nice to have:
SAT - Site Acceptance Test
FAT Factory Acceptance Test
Beginn: 01.08.2016
Dauer: 31.12.2016
Branche: Medizin/Healthcare