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.