Validation Manager - New Facilities

About the role

DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is looking for a Validation Manager for its New Facilities Department. The position reports to the Senior Validation Manager and is based in Kryoneri, Athens.

Key responsibilities

• Lead and coordinate validation activities for new pharmaceutical manufacturing facilities, utilities, equipment and computerized systems.
• Ensure qualification and validation follow cGMP, FDA, EU GMP and internal quality requirements.
• Review and approve validation documentation such as Validation Master Plans, user requirement specifications, risk assessments, IQ/OQ/PQ protocols and validation reports.
• Work with Engineering, Projects, Production, Maintenance, Automation and Quality teams during design, construction, commissioning, qualification and startup.
• Maintain 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.
• Support investigations, deviations, CAPAs, change controls and requalification linked to validation.
• Take part in regulatory inspections, customer audits and internal audits.
• Lead, coach and develop validation team members and support cross-functional projects such as expansions, equipment installations, technology transfers and process improvements.

Required profile

• Bachelor's degree in Life Sciences or Engineering; an MSc is an asset.
• Minimum 6 years of experience in pharmaceutical manufacturing, validation, engineering, technical operations or quality assurance in a regulated environment.
• Proven experience qualifying and validating pharmaceutical facilities, utilities, production equipment and computerized systems.
• Experience with commissioning, startup, expansion or greenfield projects is a strong advantage.
• Demonstrated experience leading teams or coordinating multidisciplinary projects.
• Excellent communication in Greek and English.

Required skills

• Strong knowledge of the validation lifecycle (DQ, IQ, OQ, PQ, requalification) and calibration programs.
• Good understanding of EU GMP Annex 1, FDA regulations, 21 CFR Part 11 and data integrity.
• Project management, planning and stakeholder management.

What we offer

• Competitive remuneration.
• Continuous learning and development opportunities.
• A friendly and challenging working environment.