CSV Validation Specialist

vor 3 Wochen

Bern, Bern, Schweiz Capgemini Vollzeit

About Capgemini Engineering

At Capgemini Engineering, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace and invite you to be part of our success story, where we provide training, tools, and foundations for your professional and personal growth.

Job Description

We are looking for an experienced CSV Validation Specialist to join our team.

  • Assess and produce CSV packages on assigned projects, taking accountability for the work to be produced.
  • Plan, coordinate, and execute all phases for computer system validation of production and QC Lab systems, including validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
  • Prepare, review, and approve technical and GMP-related documentation, such as URS, impact/risk assessment, Master plans, qualification/validation documentation.
  • Understand customer needs and define electronic records requirements for computerized systems, adhering to regulations 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 ensuring that changes introduced in the organization of systems, procedures, processes, and formulas are managed, assessing and resolving all aspects of equipment/computerized systems commissioning and qualification processes.

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.
  • Knowledge 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).
  • 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-border due to tax regulations).
  • 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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