CSV Engineer

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit
About agap2 - HIQ Consulting

We are a European engineering and operational consulting group founded in 2005, specializing in various industries, including Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology.

As a trusted partner, we support our clients in achieving their project goals by providing expert advice and skills.

Our team is agile and adaptable, with a passion for exploring the complexities of large-scale projects.

Job Responsibilities

The CSV Engineer - Validation Expert will be responsible for ensuring the validated state of computerized systems on manufacturing sites, including laboratory equipment.

Key tasks include:

  • Creating risk analyses, traceability matrixes, and validation protocols in CSV documents.
  • Organizing the review of CSV documents by QA teams.
  • Executing CSV tests and supporting CSV timelines.
  • Writing CSV reports.
  • Collaborating closely with CSV and CQV lead Engineers.
  • Interacting with Process Engineers, Automation Teams, PM, and QA.
  • Ensuring GAMP5 compliance and following ASTM guidelines.
Requirements

To be successful in this role, you will need:

  • An engineering diploma in Biotechnology, Bioprocess, or Chemical Engineering, or a similar field.
  • A minimum of 3+ years of experience in Commissioning, Qualification, and Validation, including CSV, with strong experience in managing complex pharmaceutical projects.
  • Expertise in automation and vertical integration, as well as data management under validated computer systems.
  • Knowledge of planning CQV activities and leading large senior reports.
  • A proven management experience in an EMA/FDA regulated environment, with good knowledge of current ICH, PIC/S, EU, and US regulatory requirements and their implementation.
  • Fluency in English and German.
Benefits

As a member of our team, you will enjoy:

  • A stable and sustainable job with opportunities for growth and development.
  • A collaborative and dynamic work environment with real human values.
  • Access to training with accredited and certified centers.
  • A local management team to support you in achieving your missions and developing your career.
  • Participation in a diverse and challenging project portfolio.

We are an equal opportunities employer and welcome applications from Swiss and EU citizens.

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