Quality Assurance Validation Engineer

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).

Requirements

• 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.

Benefits

The company offers competitive compensation, continuous training & career development opportunities and a friendly working environment.