CSV Engineer

vor 5 Monaten

Bern, Schweiz Capgemini Vollzeit

About Us

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 .

Job description

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.

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 


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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