CSV Specialist

Job content

At Pauwels Consulting, a leading Belgian firm, we specialize in delivering top-notch compliance and validation services to the pharmaceutical industry. We’re looking for a skilled Medior to Senior CSV Specialist to join our vibrant team and work closely with our clients, mainly based in Wallonia. In this role, you’ll ensure their computer systems and software used in manufacturing and laboratory processes are fully validated and compliant. Your focus will be on the validation of automated systems, making sure everything runs smoothly and efficiently.

Responsibilities :

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.

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