QA VALIDATION ENGINEER

CSV QA Validation engineer J&j, Bern, 06/2024 to 09/2025
Johnson and Johnson - Bern, Switzerland
CSV QA Engineer at Jansen Vaccine Bern
➢Review and approval of Protocols
➢ Assist in Audits
➢Working to GAMP 5 standards
➢Review and approval of Validation plans, RTM, FMEA, CAPA
➢Attending daily meetings to plan QA tasks. Help in the review and approval of , SIA and RA
➢Ensure GMP Compliance is adhered to throughout an investigative process
➢Liaise with SME to determine severity of Non conformances and determine if a Capa or Deviation is required
➢Investigate CSV related deviations and assist in drafting deviations.

PQA ENGINNER, 02/2024 to 06/2025
FUJI FILM - HILLEROD, DENMARK
QA CSV engineer at Fuji Film Denmark
➢Review and approval of RA, FMEA, Validation Plans, RTM in kneat.
➢Review and approval of Executed protocol in kneat
➢Taking Part in meeting to decide leveraging of Protocols from commissioning and Qualification.

CSV-MES VALIDATION ENGINEER, 08/2018 to 10/2023
PQE Engineer Feb 2024-Jun 2025

Fuji Film Denmark

➢Review and approval of Protocols
➢ Assist in Audits
➢Working to ASTM E2500 standards
➢Review and approval of Validation plans, RTM, FMEA, CAPA
➢Attending daily meetings to plan QA tasks.
➢Ensure GMP Compliance is adhered to throughout an investigative process and ensuring punches are closed.
➢Liaise with SME to determine severity of Non conformances and determine if a Capa or Deviation is required
➢Approval of Commissioning and Qualification protocols.