CSV Validation Specialist

vor 4 Wochen

Bern, Bern, Schweiz Capgemini Vollzeit

About the Role

At Capgemini Engineering, we are seeking an experienced CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will be responsible for assessing and producing CSV packages on assigned projects, taking accountability for the work to be produced.

Key Responsibilities

  • Plan, coordinate, and execute all phases for computer system validation of production and QC Lab systems, including validation plans, FMEA, RTM, DQ, IQ, OQ, and PQ test scripts.
  • Prepare, review, and approve technical and GMP-related documentation, including URS, impact/risk assessment, master plans, and 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 ensuring 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.

Requirements

  • 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.

What We Offer

  • 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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