Pauwels Consulting
CSV Specialist
Pharma & Sciences - Validation - braine l'alleud
  • Validation Planning and Execution:
    • Develop and implement validation strategies, plans, protocols, and reports for computer systems used in GMP, GLP, and GCP environments.
    • Lead and execute CSV projects for new and existing automated systems, ensuring compliance with regulatory requirements (FDA, EMA, etc.).
  • Risk Management:

    • Perform risk assessments and ensure proper mitigation strategies are in place for computer systems.
    • Conduct periodic reviews and revalidations of existing systems to ensure ongoing compliance.
  • Documentation:

    • Create and maintain comprehensive validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Traceability Matrices (TM).
    • Ensure all validation documentation is complete, accurate, and audit-ready.
  • Compliance and Audits:

    • Support internal and external audits related to computer systems validation.
    • Ensure all systems comply with 21 CFR Part 11, EU Annex 11, and other applicable regulations.
  • Collaboration and Training:

    • Collaborate with cross-functional teams including IT, Quality Assurance, Manufacturing, and Laboratory personnel to ensure validation activities are aligned with business needs.
    • Provide training and guidance to junior staff and other team members on CSV principles and best practices.
  • Client Engagement:

    • Serve as the primary point of contact for our clients in Wallonia, ensuring their needs are met with high-quality service and expertise.
    • Build and maintain strong relationships with clients, understanding their specific requirements and delivering tailored solutions.
  • Continuous Improvement:

    • Stay updated with industry trends and regulatory changes related to computer system validation.
    • Identify opportunities for process improvements and implement changes to enhance the efficiency and effectiveness of validation activities.
  • Reference number: 79509

    What are we looking for?

    • Bachelor’s degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.
    • 5+ years of experience in computer system validation within the pharmaceutical or biotechnology industry.
    • Proven experience with automation CSV, including the validation of automated manufacturing systems, laboratory instruments, and IT systems.
    • In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, GAMP 5, etc.).
    • Strong project management skills with the ability to manage multiple projects simultaneously.
    • Excellent analytical, problem-solving, and documentation skills.
    • Strong interpersonal and communication skills, with the ability to work effectively in a team environment.
    • Proficiency in French and English; additional language skills are a plus.
    • Certifications such as PMP, Six Sigma, or relevant CSV certifications are a plus.

    What do we offer?

    • Challenging projects based on your interests and skills
    • Personal follow-up and clear, transparent communication both before and after commencement of employment
    • Possibility to follow extra training
    • Inspiring network events and legendary after work drinks
    • Strong network of industry leading clients
    • Expertise within IT, Engineering and Life Sciences
    • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
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    Joachim Cemolin
    Joachim Cemolin
    Talent Acquisition Specialist Life Sciences
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