validation engineer
Sep 6, 2026 · DEMO S.A. Pharmaceutical Industry
What you'll do
- Issue Quality Risk Management reports on design, qualification, validation, control, and monitoring of new pharmaceutical facilities
- Prepare or review URS and qualification/validation protocols and reports (DQ/IQ/OQ/PQ) ensuring credibility
- Develop, issue, and revise QA procedures (SOPs) for activities in new facilities
- Lead deviation investigations and perform root cause analysis with CAPA follow-up
- Verify compliance of production and support areas with legislation, standards, and internal procedures
- Execute and document FAT/SAT prior to commissioning; support change control and requalification
- Perform equipment, utilities, and cleanroom qualification and temperature mapping
- Conduct formal risk analyses (FMEA/FMECA/FTA/HACCP) and implement mitigation measures
- Support Computerised Systems activities in line with EU Annex 11 and GAMP 5 principles
- Ensure ongoing validated status of equipment/systems and adherence to cGMP and data integrity (ALCOA+)
- Participate in Annex 1 compliant activities including contamination control, EM qualification, and barrier technologies
Key requirements
- 2+ years' experience
- Risk Management Tools including FMEA, FMECA, FTA, HACCP
- Cleaning Validation, Process Validation, and Facility Design
- FDA 21 CFR 210/211 and FDA 21 CFR Part 11 regulatory knowledge
- EU GMP including Annex 15, Annex 11, and Annex 1 standards
- Qualification/Validation Protocols (DQ/IQ/OQ/PQ)
- Quality Risk Management, Deviation Investigations and Root Cause Analysis
- Computerized Systems Validation in compliance with CSV/CSA and GAMP 5
- Data Integrity principles including ALCOA+
- MS Office proficiency
- Engineering / Life Sciences / Any Fieldpreferred
Benefits
- The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
About the job
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.
About the company
DEMO is a dynamic Greek industrial and commercial organization, specializing in the development, production and supply of pharmaceutical products.
The company is the largest supplier of injectables for public hospitals in Greece, exports 80% of its annual production and is recognized as one of the official suppliers of the United Nations, UNICEF, the World Health Organization (WHO), Doctors Without Borders and the International Committee of the Red Cross. With over 3,300 circulation licenses in 86 countries worldwide, the largest factory in SE Europe and over 1,400 employees, DEMO paves the way for pharmaceutical self-sufficiency for Greece and Europe.
Today, DEMO implements investments of €356 million, strengthening production and R&D, while entering the development and production of active ingredients and Biotechnology.
At the same time, the company is committed to ensuring equality, diversity and inclusion in the working environment and has adopted -within this context- the Diversity Charter for Greece.
DEMO moves "Always Forward" driven by its corporate philosophy of providing quality and reliable pharmaceutical products, for everyone.
About the company
DEMO is a dynamic Greek industrial and commercial organization, specializing in the development, production and supply of pharmaceutical products.
The company is the largest supplier of injectables for public hospitals in Greece, exports 80% of its annual production and is recognized as one of the official suppliers of the United Nations, UNICEF, the World Health Organization (WHO), Doctors Without Borders and the International Committee of the Red Cross. With over 3,300 circulation licenses in 86 countries worldwide, the largest factory in SE Europe and over 1,400 employees, DEMO paves the way for pharmaceutical self-sufficiency for Greece and Europe.
Today, DEMO implements investments of €356 million, strengthening production and R&D, while entering the development and production of active ingredients and Biotechnology.
At the same time, the company is committed to ensuring equality, diversity and inclusion in the working environment and has adopted -within this context- the Diversity Charter for Greece.
DEMO moves "Always Forward" driven by its corporate philosophy of providing quality and reliable pharmaceutical products, for everyone.