Validation Engineer

Vertragsart:
Vor Ort
Start:
keine Angabe
Dauer:
keine Angabe
Von:
Harvey Nash IT Recruitment Switzerland
Ort:
Solothurn
Eingestellt:
21.01.2017
Land:
flag_no Schweiz
Projekt-ID:
1273105

Warning
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Role: Computer System Validation (CSV) Engineer- Senior
Place of work: Zuchwil
Project Start date:
Project End date:
Workload/weekly working hours: 100%/40 hours

Responsible for supporting Computer Systems Compliance activities applicable to country specific regulations (eg FDA, Health Canada), international standards (eg MDD, ISO) and as appropriate best business practices (eg GAMP 5). This includes the creation, execution and coordination of GxP computer system validation - Equipment activities.
This position is related to a transformation project for 2 years.

Duties and responsibilities:

. Ensure personal compliance and support departmental compliance to Corporate Compliance, Human Resources and training requirements.
. Perform the following duties as necessary to support company needs: direction of personnel within those projects, through project completion
. Assist in the establishment and maintenance of procedures, tools and methodologies to cover all computer systems life cycle phases.
. Follow policies and procedures for computer systems validation - Equipment.
. Advise and consult within DePuy Synthes and with suppliers to facilitate timely and complete resolution to computer systems validation - Equipment issues.
. Partner on departmental or company-wide projects for computer systems validation
. Equipment including, but not limited to e-records/e- signature compliance.
. Partner with IT and System Owner to ensure compliance of GxP computer systems life cycle procedures, tools and methodology.
. Manage or assist with audits of current and prospective suppliers of software applications and services. Maintain a working knowledge of applicable regulations and standards associated with computer systems validation in order to maintain a state of compliance while providing innovative solutions to meet changing business needs.
. Assist in 3rd party assessments of the company's computer systems validation

Education:

. Bachelors degree preferred in computer science or other technical field or greater than 4-6 years Computer System Validation - Equipment experience.
. Knowledge of software development and testing methodologies (S/W life cycle) Six
. Sigma/Lean Certification a plus
. ASQ Certification as a Software Quality Engineer is a plus

Experience:

. Desired - experience in managing and/or in performing audits in a regulated environment.
. Direct experience working in and/or supervising computer systems - equipment compliance activities in a medical device and/or manufacturing and/or pharmaceutical company.
. Ability to prioritize and manage multiple projects consisting of varying degrees of complexity
. Ability to analyse complex problems and apply practical solutions
. Self-motivator
. Problem resolution
. Excellent Organizational and Communication Skills (written and verbal)
. Excellent team spirit and capacity of interacting within a multi-functional project team
. Languages: Fluent German, Business English (written and spoken). Good knowledge of French