Computerized System Validation Engineer

Computerized System Validation 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 CSV Engineer for our client based in Bern.

Tasks
- Planning and implementation of qualification/validation activities and projects of new and existing computer systems according to client's internal and external requirements for all departments
- Advisory and support of application owners to build and maintain GMP conform systems
- Support and consulting during projects handling GxP critical computer systems
- Approving specific computer system validation documentation and acting as software quality assurance
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Performing CSV trainings

Focus:
- Take part of CSV activities
- Reviewing/writing/updating of documentation (ie SOP, Work Instructions, Protocols like IQ, OQ)
- Cooperate and collaborate with stakeholders/internal team members/suppliers (deep info exchange regarding system specifications)

Extended Duties:
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc).

Requirements:
- Higher education (Engineer or similar) and background in IT and at least 5 years work experience.
- Responsibility in similar management position or extended experience as executer required.
- Knowledge of national and international regulations and standards, eg. GAMP5, FDA QSR, 21 CFRPart 820, Part 11
- Experience Pharma is a must (5 years)

Minimal language skills:
- English & German fluent (spoken, written), French nice to have

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!