About Capgemini Engineering Switzerland
We value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and provide training, tools and foundations for your professional and personal growth.
Job Description
* Assess and produce the CSV package(s) on an assigned project. Take accountability for the work to be produced.
* 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.
Your Profile
* Bachelor/Masters Degree in technical or natural sciences.
* A minimum of 4 years of working experience with CSV.
* A minimum of 3 years of working experience within pharma or a biotech company.
* Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
* Experience on defining strategy and validating computerized manufacturing equipment (CSV context).
* Excellent communication skills.
* Analytical thinking and problem-solving ability.
* Ability to work under minimal supervision; Assess priorities and work well under pressure in a fast-paced environment.
* Ability to effectively work as part of a multidisciplinary, international team.
* Fluent in English.
Benefits
* Between 30% and 70% remote work in agreement with your manager and client needs (40% for cross boarders due to tax regulation)
* Options to order ergonomically proven equipment (monitor & chair) for your home-office premises
* Support for trainings, formation upon agreement with the manager
* Contribution on gym subscription
* Trust-based managerial culture
* Team rituals and get togethers