About The Role

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.
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.