Validation Engineer

About the role

As a Validation Engineer at DEMO SA, you will support the launch of our new sterile pharmaceutical manufacturing plant in Tripoli, Arcadia. You will ensure that all equipment, utilities and processes meet regulatory and quality standards throughout the full qualification and validation lifecycle.

Key responsibilities

• Prepare and review User Requirements Specifications, qualification/validation protocols and reports (DQ, IQ, OQ, PQ).
• Develop, issue and revise QA procedures (SOPs) for activities in the new facilities.
• Lead deviation investigations, perform root‑cause analysis and manage CAPA follow‑up.
• Execute FAT/SAT, support change control, re‑qualification and equipment qualification, including temperature mapping.
• Conduct formal risk analyses (FMEA, FMECA, FTA, HACCP) and implement mitigation measures.
• Support computerized systems validation in line with EU Annex 11 and GAMP 5.
• Ensure ongoing compliance with cGMP, data integrity (ALCOA+), and Annex 1 sterile manufacturing requirements.

Required profile

• BSc in Engineering, Life Sciences or related field (MSc a plus).
• Minimum 2 years of experience in industrial production, preferably pharmaceutical validation for injectables.
• Strong command of Greek and English.
• Proficient with MS Office.

Required skills

• Risk‑management tools: FMEA, FMECA, FTA, HACCP.
• Cleaning Validation, Process Validation, Facility Design.
• Regulatory knowledge: FDA 21 CFR 210/211, 21 CFR Part 11, EU GMP Annex 15, Annex 11, Annex 1.
• Equipment qualification, temperature mapping, FAT/SAT, change control, re‑qualification.
• Computerised Systems Validation (CSV/CSA) following GAMP 5.
• cGMP, data integrity (ALCOA+).

What we offer

• Competitive remuneration.
• Continuous learning and development opportunities.
• A friendly, challenging working environment.