Computer System Validation (CSV) Engineer GxP Audits Regulations GAMP

Computer System Validation (CSV) Engineer

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

We are looking for a Computer System Validation (CSV) Engineer for our client based in Zuchwil, who will be 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.

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 our client's 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 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 - Equipment program.

Education:

- Bachelor's 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.

Non Technical Skills and Additional Details

- Ability to prioritize and manage multiple projects consisting of varying degrees of complexity
- Ability to analyze 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

Whether this role is the right fit or you would like to see if there are others that do, our dedicated and expert team is looking forward to hearing from you.

Good to know you!