At Capgemini Engineering Switzerland, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and would like to invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal growth. We are looking for an experienced CSV Engineer.
Responsibilities
* 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, and 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 systems 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 in defining strategy and validating computerized manufacturing equipment (CSV context).
* 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.
We look forward to receiving your application. Capgemini Engineering only accepts direct applications (no recruitment agencies). Due to Swiss regulations, we only consider Swiss or EU/EFTA applicants or applicants with a valid work permit.
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