validation manager
Sep 6, 2026 · DEMO S.A. Pharmaceutical Industry
What you'll do
- Lead and coordinate validation activities for new pharmaceutical manufacturing facilities, utilities, equipment, and computerized systems
- Ensure qualification and validation activities comply with cGMP, FDA, EU GMP, and internal quality standards
- Review and approve validation documentation such as Validation Master Plans, risk assessments, qualification protocols, and validation reports
- Collaborate with Engineering, Projects, Production, Maintenance, Automation, and Quality teams during design, construction, commissioning, qualification, and startup phases
- Maintain validated state of facilities, equipment, utilities, and computerized systems throughout their lifecycle
- Monitor and maintain validation and calibration programs for critical systems and equipment
- Support investigations, deviations, CAPAs, change controls, and requalification activities related to validation
- Participate in regulatory inspections, customer audits, and internal audits providing validation expertise
- Lead, coach, and develop Validation team members promoting quality, compliance, and continuous improvement
- Support cross-functional projects involving facility expansions, equipment installations, technology transfers, and process improvements
Key requirements
- 6+ years' experience
- Qualification and validation of pharmaceutical facilities, utilities, production equipment, and computerized systems
- Validation lifecycle activities including DQ, IQ, OQ, PQ, requalification, and calibration programs
- Good understanding of EU GMP, Annex 1, FDA regulations, 21 CFR Part 11, and Data Integrity requirements
- Project management, planning, and stakeholder management skills
- Leading, coaching, and developing Validation team members
- Experience with commissioning, startup, expansion, and greenfield pharmaceutical projects
- Review and approval of validation documentation including VMPs, risk assessments, qualification protocols, and validation reports
- Collaboration with Engineering, Projects, Production, Maintenance, Automation, and Quality teams
- Handling investigations, deviations, CAPAs, change controls, and requalification activities
- Strong analytical thinking and problem-solving
- Excellent communication skills in Greek and English
- Ability to manage multiple priorities in a fast-paced manufacturing and project environment
- Life Sciences / Engineeringpreferred
Benefits
- The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
About the job
At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented candidate for the position of Validation Manager for New Facilities Department. The position reports to the Senior Validation Manager and is based in Kryoneri.
Responsibilities
Lead and coordinate Validation activities for new pharmaceutical manufacturing facilities, utilities, equipment, and computerized systems.
Ensure qualification and validation activities are executed in compliance with cGMP, FDA, EU GMP, and internal quality requirements.
Review and approve validation documentation, including Validation Master Plans (VMP), User Requirement Specifications, risk assessments, qualification protocols (IQ/OQ/PQ), and validation reports.
Collaborate closely with Engineering, Projects, Production, Maintenance, Automation, and Quality teams during the design, construction, commissioning, qualification, and startup phases of new facilities.
Ensure the validated state of facilities, equipment, utilities, and computerized systems throughout their lifecycle.
Monitor and maintain validation and calibration programs for critical systems and equipment.
Review and support investigations, deviations, CAPAs, change controls, and requalification activities related to validation processes.
Participate in regulatory inspections, customer audits, and internal audits, providing validation expertise and support.
Lead, coach, and develop Validation team members while promoting a culture of quality, compliance, and continuous improvement.
Support cross-functional projects related to facility expansions, equipment installations, technology transfers, and process improvements.
Requirements
Bachelor’s degree in Life Sciences or Engineering field. An MSc degree will be considered an asset.
Minimum 6 years of experience in pharmaceutical manufacturing, validation, engineering, technical operations, or quality assurance within a regulated environment.
Proven experience in qualification and validation of pharmaceutical facilities, utilities, production equipment, and computerized systems.
Experience supporting commissioning, startup, expansion, or greenfield pharmaceutical projects will be considered a strong advantage.
Strong knowledge of validation lifecycle activities including DQ, IQ, OQ, PQ, requalification, and calibration programs.
Good understanding of EU GMP, Annex 1, FDA regulations, 21 CFR Part 11, and Data Integrity requirements.
Demonstrated experience leading teams or coordinating multidisciplinary project activities.
Strong project management, planning, and stakeholder management skills.
Excellent communication skills in both Greek and English.
Ability to manage multiple priorities in a fast-paced manufacturing and project environment.
Strong analytical thinking, problem-solving mindset, and ability to drive decisions through collaboration and influence.
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.