CSV Engineer

Experis is a leading global provider of personalized recruitment solutions and professionals in the IT sector.

On behalf of one of our clients, who's in the pharmaceutical industry, we're looking for a CSV Engineer

Location: Bern

Work Model: Hybrid / 3 days on site reqired

Workload: 100%

Seniority: Expert

Contract: 5 months / possible extension

Requirements

In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:

• Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
• Validation Master plans are up to date and established for all ongoing projects

Essential duties

• Assess and produce the CSV package(s) on an assigned project. Taking accountability for the work to be produced. § Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts. § Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
• Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards
• Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems
• Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
• Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning, and qualification process are assessed and resolved.

Due to Swiss work permit restrictions, we can only consider applications from Swiss citizens, EU citizens, or those with a current work permit for Switzerland.

If you're interested, please feel free to contact me or quickly apply through the system.