Quality Assurance Validation Engineer
Demo S.A.· Quality Assurance
About this role
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a high caliber Quality Assurance Validation Engineer to join our team. This position is based in Athens, Kryoneri. As a Validation Engineer, you will ensure compliance and quality across our sterile pharmaceutical installations, supporting the full CQV lifecycle and contributing to a robust Contamination Control Strategy (CCS).
Responsibilities
- Issue Quality Risk Management (QRM) reports covering design, qualification, validation, control, and on-going monitoring of facilities through the quality system.
- Prepare or review URS, qualification/validation protocols and reports (DQ/IQ/OQ/PQ) and related procedures, ensuring credibility commensurate with criticality.
- Develop, issue and revise QA procedures (SOPs) for planned activities in the facilities.
- Lead deviation investigations across production and CQV activities; perform root cause analysis and ensure effective CAPA follow-up.
- Verify that production and support areas meet current Legislation, Standards and Internal Procedures; review and track CAPAs from internal audits.
- Execute and document FAT/SAT prior to commissioning; support change control and re‑qualification.
- Perform equipment, utilities and cleanroom qualification; execute temperature mapping for controlled areas and storage.
- Conduct and document formal risk analyses (e.g., FMEA/FMECA/FTA/HACCP) and implement mitigation measures.
- Support Computerised Systems activities in line with EU Annex 11 and GAMP 5 (Second Edition) principles (CSV/CSA) as applicable.
- Ensure ongoing validated status of equipment/systems, strict adherence to cGMP and data integrity (ALCOA+).
- For sterile operations: participate in Annex 1–compliant activities (CCS, EM qualification and trending, barrier technologies).
- BSc in Engineering, Natural Sciences or related discipline (MSc considered a plus).
- ≥2 years’ relevant experience in industrial production; experience in pharmaceutical validation for injectables is preferred.
- Hands-on experience with risk management tools (FMEA, FMECA, FTA, HACCP).
- Experience in Cleaning Validation, Process Validation and facility design.
- Good understanding of FDA 21 CFR 210/211, 21 CFR Part 11, EU GMP including Annex 15 (Qualification & Validation), Annex 11 (Computerised Systems) and Annex 1 (Sterile).
- Excellent command of Greek and English; strong MS Office skills.
- Critical thinking, problem-solving, flexibility; ability to manage multiple priorities and meet manufacturing deadlines.
The company offers competitive compensation, continuous training & career development opportunities and a friendly working environment.
Frequently Asked Questions
Is the salary disclosed for the Quality Assurance Validation Engineer position at Demo S.A.?
The salary for this Quality Assurance Validation Engineer role at Demo S.A. is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Quality Assurance Validation Engineer position at Demo S.A. located?
This Quality Assurance Validation Engineer role at Demo S.A. is based in Athens, Attica, Greece. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Quality Assurance Validation Engineer role at Demo S.A. full-time or part-time?
This is listed as a Full time position. It is posted as a Quality Assurance Validation Engineer role in the Quality Assurance department at Demo S.A..
Which team or department does the Quality Assurance Validation Engineer at Demo S.A. belong to?
This Quality Assurance Validation Engineer position is part of the Quality Assurance department at Demo S.A.. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Quality Assurance Validation Engineer position at Demo S.A.?
Click the "Apply Now" button on this page. You will be redirected to Demo S.A.'s official application portal hosted on workable where you can submit your application directly.
When was the Quality Assurance Validation Engineer job at Demo S.A. posted?
This Quality Assurance Validation Engineer position at Demo S.A. was posted on Sep 17, 2026. Apply as soon as possible — early applications are often reviewed first.
Quality Assurance Validation Engineer
Demo S.A.
You'll be redirected to Demo S.A.'s official application page on workable.