CSV Engineer

Job content

A global pharmaceutical giant is looking for a Computer System Validation Engineer to join them on a contract basis in Bern, Switzerland. The contract will start ASAP and run to the end of 2023. There is a high likelihood that the contract will be renewed for all of 2024.

A minimum of 3 days per week of site presence is required. Due to the nature of the position and the tasks to be performed, it may be required to be more than 3 days per week on site, based on demand. Therefore, living in a regular commutable distance from Bern- Bumplitz is advisable.

Within this role, you will be in charge of Computer System Validation (CSV) activities for the 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 lead 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, Validation Reports.
• Perform CSV periodic review of equipment and systems.
• 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 in collaboration with internal and external partners
• Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
• Coordination and oversight of external subcontractors / software suppliers when required
• Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV

Education & Experience

• Bachelor/master’s degree in technical or natural sciences.
• Ability to work in a fast & changing environment.
• A minimum of 3 years of working experience within pharma or a biotech company.
• Experience on defining strategy and validating computerized manufacturing (CSV context).
• Experience on validating software & hardware infrastructure (e-g: servers, network software services).
• A minimum of 4 years of working experience with CSV.
• Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
• Experience on validating complex computerized analytical equipment (QC Laboratory equipment).
• Basic know-how of Validation requirements according to cGMP regulations.
• Basic know-how of quality assurance principles.
• Fluent English. Knowledge of German would be a bonus.

The deadline for applications is 29-09-23. Please apply now with an updated CV.