Quality Assurance Validation Engineer at Demo S.A.

Tripoli, Peloponnese, Western Greece and the Ionian, Greece -

Full Time

Start Date

Immediate

Expiry Date

11 Jan, 26

Salary

0.0

Posted On

13 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Validation Engineering, Risk Management, Cleaning Validation, Process Validation, FDA Regulations, GMP Compliance, Critical Thinking, Problem Solving, Root Cause Analysis, CAPA, Temperature Mapping, Computerised Systems, Sterile Operations, Contamination Control, Documentation

Industry

Pharmaceutical Manufacturing

Description

DEMO SA is one of Europe’s leading pharmaceutical manufacturers. We are expanding with new state-of-the-art manufacturing facilities in Tripoli, Arcadia. All roles below are full-time, on-site (day shift) at the new plant, with occasional trips to Kryoneri for training. About the role 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. BSc in Engineering, Natural 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. The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

Responsibilities

The Validation Engineer will ensure compliance and quality across new sterile pharmaceutical installations, supporting the full CQV lifecycle. Responsibilities include issuing Quality Risk Management reports, preparing qualification protocols, leading deviation investigations, and ensuring adherence to regulations.