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QA CSV Specialist – Manufacturing Automation Systems
Ensure CSV compliance for automation systems through validation and documentation.
Job
About the Role
You will support the QA Engineering department in ensuring that all Computer System Validation (CSV) regulatory and procedural requirements are met throughout the entire lifecycle of manufacturing automation systems (concept, project, operational, and retirement phases). This role is critical for maintaining compliance with cGMP regulations and internal standards.
Key Responsibilities
- Review and approve CSV documentation and records, including:
- SOPs, User Requirements, Impact/Risk Analyses
- Test Plans, Test Scripts, Change Controls, CAPAs
- Ensure compliance with regulations, guidelines, and company standards.
- Participate in engineering teams for new or upgraded systems and processes.
- Provide advice and support for CSV-related activities, ensuring cGMP compliance.
- Address and follow up on deviations during CSV execution.
- Communicate quality, compliance, and planning status to QA Qualification team members.
Profile
Required Knowledge & Skills
- Industry Experience
- Background in chemical and/or pharmaceutical industry with CSV for automation systems.
- Regulatory Knowledge
- Strong understanding of cGMP regulations and guidelines.
- Technical & Analytical Skills
- Ability to translate technical information for different organizational levels.
- Skilled in assessing urgency, criticality, and impact of decisions.
- Soft Skills
- Ability to multitask and manage multiple projects simultaneously.
- Independent worker and effective team player in cross-functional environments.
- Strong communication skills.
- Languages
- Fluent in English and Dutch (written and spoken).
Specific System Knowledge
- Manufacturing automation systems (e.g., DeltaV).
- Change management tools (e.g., Comet).
- Document management systems (e.g., TruVault).
- Test tools (e.g., Kneat).
Benefits
As an AKKODIS Team member, you will be:
- Onboarded in your position via a buddy process
- Supported in your career by your Business Manager
- Actor of your training plan and your personal and professional development
- Benefiting from a permanent contract
- Benefiting from a competitive salary package including several extra-legal benefits
Company profile
Akkodis is a global digital engineering consulting company that empowers organizations to accelerate and innovate. With roots in IT and engineering, research & development (ER&D), we combine technology and talent to drive our clients’ digital transformation.
