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CSV Engineer

vor 4 Monaten

Zürich, Zürich, Schweiz Capgemini Suisse SA Vollzeit
Job Description

Follow your passion in a role where you will be exposed to the technologies and processes that leading global companies utilize, and join our innovative team as,

CSV Engineer - to be based in Bern

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, 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.

Requirements

  • Bachelor/Master's 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.

If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application. Otherwise, please kindly consider that your application is unsuccessful.

Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.

Capgemini Engineering is an EEO and Affirmative Action Employer of Females/Minorities/Individuals with Disabilities.

Our offer

  • A permanent contract with the leader in innovation and high-tech engineering consulting.
  • A multi-stage model with career opportunities through specialization prospects with over 250'000 consultants around the world and a Group revenue of EUR. 17 Bn, the Capgemini Group is the undisputed global leader in Engineering and R&D services (ER&D).
  • In Switzerland, Capgemini employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Bern, Lausanne and Geneva.
  • 30% to 70% remote work in agreement with your line manager and client needs.
  • Trust-based managerial culture.
  • Team rituals and get togethers.
  • Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.