- Company Name
- ClinChoice
- Job Title
- Quality Assurance CSV Engineer
- Job Description
-
**Job Title:** Quality Assurance CSV Engineer
**Role Summary:**
Lead and manage Computer System Validation (CSV) for Car‑T biomedical systems, ensuring full compliance with cGMP, regulatory standards, and internal SOPs throughout the product lifecycle. Act as cross‑functional mediator, audit spokesperson, and continuous improvement champion for CSV processes.
**Expectations:**
- Serve as independent CSV process owner for local applications.
- Maintain up‑to‑date Validation Master Plans and ensure timely execution.
- Review, approve, and audit CSV documents (SOPs, requirements, impact analyses, validation plans, test protocols).
- Participate in change, deviation, incident, and audit activities, providing corrective/preventive actions.
- Deliver periodic quality compliance reports; prepare for internal and supplier audits.
- Train stakeholders on CSV regulations, GAMP, and e‑records best practices.
- Keep abreast of evolving international regulations and implement improvements.
- Communicate effectively across all organizational levels in English and Dutch.
**Key Responsibilities:**
1. Own CSV management for computer systems (applications, BSL‑4 labs).
2. Update Validation Master Plans; ensure execution schedule adherence.
3. Review, approve, and document CSV artifacts (SOPs, URs, impact/risk analyses, validation plans, test scripts).
4. Liaise with IT/engineering on new system introductions; advise on CSV and cGMP aspects.
5. Engage in cross‑functional teams for departmental objectives.
6. Participate in change management, addressing deviations from qualification/validation.
7. Evaluate incidents; recommend corrective/preventive actions; notify QA focus when required.
8. Produce quality system compliance reports (metrics, trends).
9. Prepare and represent the organization during audits and inspections.
10. Follow up on CSV actions triggered by audits, FIRs, CAPAs, QIPs, MAPs.
11. Conduct internal and supplier audits; guide auditees to regulatory compliance.
12. Serve as CSV and Part 11 subject‑matter expert for Car‑T.
13. Maintain current knowledge of international regulations, guidelines, and new evolutions (21CFR 11, 210, 211; EU Directives 75/319/EEC, 2003/94/EC, Volume 4; GAMP; ISO/IEC 27001 & related) through courses, conferences, and literature.
14. Develop and deliver regulatory CSV training materials to Car‑T staff.
15. Foster innovative practices and continuous improvement within the CSV domain.
**Required Skills:**
- Deep knowledge of cGMP (21CFR 11, 210, 211, EU Directives)
- Proficiency in GAMP guidelines and risk‑based electronic record compliance
- Understanding of software development and testing processes
- Experience in Quality Auditing and metric‑driven quality systems
- Strong analytical, problem‑solving, and decision‑making abilities
- Excellent communication in English and Dutch (written & spoken)
- Ability to translate technical CSV concepts for diverse audiences
- Project management and multitasking across concurrent projects
- Familiarity with MES, LIMS, PLCs, warehouse, monitoring, IRIS, Comet, TruVault, Summit, Microsoft OS, and test tools (qTest, KNEAT)
**Required Education & Certifications:**
- University/Bachelor’s degree (or equivalent) in life sciences, pharmaceutical sciences, engineering, or related field.
- Relevant certifications in CSV, GAMP, or regulatory compliance (e.g., CPC, GAMP‑A, or equivalent) preferred.
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