Computer System Validation (CSV) Engineer - Senior (m/f)

REFERENZNUMMER:

328341/11

IHRE AUFGABEN:

-Ensure personal compliance and support departmental compliance with 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 lifecycle phases
-Follow policies and procedures for computer systems validation (equipment)
-Advise and consult within the company 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 lifecycle 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 (equipment program)

IHRE QUALIFIKATIONEN:

-Bachelor’s degree, preferably in computer science or other technical field or profound and in-depth Computer System Validation - Equipment experience
-Knowledge of software development and testing methodologies (S/W life cycle)
-Experience in managing and/or in performing audits in a regulated environment desirable
-Direct experience working in and/or supervising computer systems - equipment compliance activities in a medical device and/or manufacturing and/or pharmaceutical company
-Six-Sigma/Lean Certification is a plus
-ASQ Certification as a Software Quality Engineer is a plus
-Excellent organizational and communication skills (written and verbal)
-Excellent team spirit and capacity of interacting within a multi-functional project team
-Fluency in German and Business English (written and spoken), good knowledge of French

WEITERE QUALIFIKATIONEN:

Auditor