Beschreibung
Role: Validation Technician - Normal/Senior (Professional)
Duration: 5 months
Location: Based in Zuchwil, Solothurn but required to travel to company sites across Switzerland
Function: The Validation Technician prepares and performs validation activities in order to ensure that Synthes 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:
- 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
Non-Technical profile requirements:
- Flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow change management for internal guidelines.
- Hands-on mentality!
Language proficiencies:
-Fluent English is a must (Spoken and written) and good German (at least spoken);
Skills & Knowledge:
. Engineering Study support and Validation of process and equipment!
. 2 years of CAPA
. 4 years experience in Equipment Validation
. Knowledge of ISO Regulations
. NCR (Non conformance record)
. 3 years PFMEA
. 4 years Process Validation experience
. 2 years Quality Management experience
. Experience in Audit/Pharma/Medical or Consumer Product branch
. Technical knowledge: Desktop (Office, Login, HW, SW, e-mail)