validation engineer

As a Validation Engineer, you will ensure compliance and quality across our new sterile pharmaceutical installations in Tripoli, 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 new 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 new 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).

Employment Type

Permanent, on-site (day shift) at DEMO SA’s new manufacturing plant in Tripoli, Arcadia. Occasional trips to Kryoneri for training.

Requirements

• BSc in Engineering, Life Sciences or related discipline (MSc considered a plus).

• More than 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 remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.