Quality Assurance Validation Engineer

About the role

Demo SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is looking for a high-calibre Quality Assurance Validation Engineer based in Athens, Kryoneri. You will ensure compliance and quality across sterile pharmaceutical installations, support the full CQV lifecycle and contribute 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 or review URS, qualification/validation protocols and reports (DQ/IQ/OQ/PQ) and related procedures
• Develop, issue and revise QA procedures (SOPs) for planned activities in the facilities
• Lead deviation investigations, perform root cause analysis and ensure effective CAPA follow-up
• Verify that production and support areas meet legislation, standards and internal procedures, and track CAPAs from internal audits
• Execute and document FAT/SAT before commissioning, support change control and re-qualification
• Perform equipment, utilities and cleanroom qualification, and temperature mapping for controlled areas and storage
• Conduct formal risk analyses (e.g. FMEA/FMECA/FTA/HACCP) and implement mitigation measures
• Support computerised systems in line with EU Annex 11 and GAMP 5 (CSV/CSA)
• Maintain validated status of equipment and systems, adhere to cGMP and data integrity (ALCOA+); for sterile operations, take part in Annex 1-compliant activities (CCS, EM qualification and trending, barrier technologies)

Required profile

• BSc in Engineering, Natural Sciences or a related discipline (MSc considered a plus)
• At least 2 years' relevant experience in industrial production; pharmaceutical validation for injectables preferred
• Good understanding of FDA 21 CFR 210/211, 21 CFR Part 11, EU GMP (Annex 15, Annex 11, Annex 1) and EU Annex 1
• Excellent command of Greek and English; strong MS Office skills
• Critical thinking, problem-solving, flexibility and ability to manage multiple priorities and meet manufacturing deadlines

Required skills

• Risk management tools: FMEA, FMECA, FTA, HACCP
• Cleaning validation, process validation and facility design
• EU GMP and cGMP compliance, data integrity (ALCOA+)

What we offer

• Competitive compensation
• Continuous training and career development opportunities
• A friendly working environment