Validation Technician

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Harvey Nash IT Recruitment Switzerland
flag_no Schweiz

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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.

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.

- 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)