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CSV Engineer (Pharma) (CH)

Date Posted: August 29, 2024

Job Description

We are looking for a skilled CSV Engineer to join our pharmaceutical project team in Switzerland. As a CSV Engineer, you will be responsible for ensuring that all computerized systems are validated in compliance with regulatory requirements and industry standards. You will play a vital role in maintaining the integrity and reliability of these systems throughout their lifecycle, supporting the project’s goal of delivering high-quality pharmaceutical products.

Key Responsibilities

  • Develop and execute Computer System Validation (CSV) protocols, including IQ, OQ, and PQ, to ensure compliance with regulatory guidelines (GMP, GAMP, 21 CFR Part 11).
  • Collaborate with cross-functional teams, including Quality Assurance, IT, and Engineering, to assess and validate new and existing computerized systems.
  • Perform risk assessments to identify and mitigate potential compliance risks associated with computerized systems.
  • Prepare and review validation documentation, including Validation Plans, Test Scripts, Summary Reports, and Traceability Matrices.
  • Ensure that all validation activities are thoroughly documented and meet both internal and external audit requirements.
  • Provide technical guidance and support for the resolution of CSV-related issues during system implementation and operation.
  • Maintain a thorough understanding of the latest regulatory requirements and industry best practices related to CSV.
  • Support continuous improvement initiatives to enhance the validation process and ensure the ongoing compliance of computerized systems.
  • Train and mentor project team members on CSV procedures and regulatory requirements.

Required Qualifications and Skills

  • Bachelor’s degree in Engineering, Computer Science, or a related field.
  • At least 5 years of experience in Computer System Validation (CSV) within the pharmaceutical industry.
  • Strong knowledge of regulatory requirements, including GMP, GAMP, and 21 CFR Part 11.
  • Experience in developing and executing validation protocols (IQ, OQ, PQ).
  • Excellent documentation skills and attention to detail.
  • Strong analytical and problem-solving abilities.
  • Ability to work effectively in a cross-functional team environment.
  • Proficiency in MS Office applications and validation software tools.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

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