Validation Engineer – Sterile Pharmaceutical Manufacturing

About the role

DEMO SA, a European pharmaceutical manufacturer, is opening new state-of-the-art facilities in Tripoli, Arcadia. As Validation Engineer you will ensure compliance and quality across the new sterile installations, supporting the full CQV lifecycle and contributing to a Contamination Control Strategy (CCS). The position is permanent, full-time and on-site (day shift) at the new plant, with occasional trips to Kryoneri for training.

Key responsibilities

• Issue Quality Risk Management (QRM) reports covering design, qualification, validation, control and ongoing monitoring of new 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 new 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, and perform equipment, utilities and cleanroom qualification.
• Conduct formal risk analyses (e.g. FMEA/FMECA/FTA/HACCP) and implement mitigation measures.
• Support computerised systems work 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, Life Sciences or a related discipline (MSc considered a plus).
• More than 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 cGMP.
• Excellent command of Greek and English; strong MS Office skills.
• Critical thinking, problem-solving, flexibility and ability to manage several priorities and meet manufacturing deadlines.

Required skills

• Risk management tools: FMEA, FMECA, FTA, HACCP
• Cleaning validation, process validation and facility design
• EU GMP Annex 11 and GAMP 5 (Second Edition)

What we offer

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