CSV Engineer

4 days ago

Stockholm, Stockholm, Sweden WeQuel Full time

Life Science | Regulated Environments

WeQuel is continuously building a network of experienced CSV Engineers to support current and future assignments within pharmaceutical and life science organizations.

As a CSV Engineer, you will work with validation of computerized systems in regulated environments, ensuring compliance with applicable GxP requirements and industry standards. Assignments typically involve close collaboration with quality, IT, automation, and business stakeholders.

The role

In the role of CSV Engineer, you are responsible for planning, executing, and maintaining validation activities for computerized systems throughout their lifecycle. You contribute with strong regulatory understanding, structured documentation, and a quality-driven mindset.

Typical responsibilities

  • Plan and execute computer system validation activities

  • Develop and review validation documentation (e.g. URS, FS, RA, IQ, OQ, PQ)

  • Ensure compliance with GxP, GAMP 5, and internal quality standards

  • Support audits, inspections, and deviation handling

  • Perform risk assessments and ensure data integrity (ALCOA+)

  • Collaborate with IT, automation, and quality teams

Required background

  • Proven experience in Computer System Validation (CSV)

  • Experience working in GxP-regulated environments

  • Strong understanding of GAMP 5 and system lifecycle validation

  • Experience with validation documentation and risk-based approaches

  • Ability to communicate clearly in English and Swedish

  • Experience validating systems such as MES, LIMS, ERP, or automation systems

  • Experience supporting regulatory inspections

  • Background in pharmaceutical manufacturing or life science

Why WeQuel

At WeQuel, people come first. We work with experienced specialists and consultants in regulated industries, building long-term collaborations based on trust, transparency, and equality. As part of our network, you gain access to meaningful assignments and a consulting model where we are equal.

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