Quality Assurance Validation Engineer

About the role

Demo SA, a leading pharmaceutical manufacturer, is seeking a Quality Assurance Validation Engineer to join its Athens, Kryoneri site. The role ensures compliance and quality across sterile injectable facilities, supporting the full CQV lifecycle and contributing to a robust Contamination Control Strategy.

Key responsibilities

• Issue Quality Risk Management (QRM) reports covering design, qualification, validation, control, and ongoing monitoring of facilities.
• Prepare, review, and approve URS, qualification/validation protocols and reports (DQ/IQ/OQ/PQ) and related procedures.
• Develop, issue, and revise QA procedures (SOPs) for planned activities.
• Lead deviation investigations, perform root cause analysis, and ensure effective CAPA follow‑up.
• Verify compliance of production and support areas with legislation, standards, and internal procedures; 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, including temperature mapping for controlled areas.
• Conduct formal risk analyses (e.g., FMEA, FMECA, FTA, HACCP) and implement mitigation measures.
• Support computerized systems activities in line with EU Annex 11 and GAMP 5 principles.
• Maintain validated status of equipment/systems, ensuring cGMP compliance and data integrity (ALCOA+).
• Participate in Annex 1‑compliant sterile operations, including CCS, EM qualification, trending, and barrier technologies.

Required profile

• BSc in Engineering, Natural Sciences or related discipline (MSc a plus).
• At least 2 years of relevant experience in industrial production; pharmaceutical validation for injectables preferred.
• Hands‑on experience with risk management tools (FMEA, FMECA, FTA, HACCP).
• Experience in cleaning validation, process validation and facility design.
• Strong knowledge of FDA 21 CFR 210/211, 21 CFR Part 11 and EU GMP (Annex 15, Annex 11, Annex 1).
• Excellent command of Greek and English.
• Proficient with MS Office.

Required skills

• FMEA, FMECA, FTA, HACCP
• Cleaning Validation
• Process Validation
• Facility Design
• FDA 21 CFR 210/211, 21 CFR Part 11
• EU GMP Annex 15, Annex 11, Annex 1
• MS Office

What we offer

• Competitive compensation
• Continuous training and career development opportunities
• Friendly working environment