Work Schedule Standard (Mon-Fri) Environmental Conditions Office Purpose of role/responsibility: Lead the Equipment Validation Compliance Team at Thermo Fisher Scientific, ensuring flawless processes and world-class standards. Lead an ambitious team, driving excellence and compliance in a dynamic and collaborative environment. Support manager in the team coordination for the review of equipment validation documents. - Coordinate with the manager to determine team priorities and ensure the successful implementation of validation document review processes. Primary activities: - Lead and support your team in achieving outstanding results and maintaining high standards of quality and compliance. Analysis of technical documentation: - Conduct detailed analyses of technical documents to verify compliance with regulatory standards and company procedures. Ensure the review of the technical documentation for equipment qualification (IQ-OQ-PQ protocols and reports), in compliance with current regulations (GMP standards, FDA, etc.) and company procedures. - Coordinate the stringent review of qualification protocols and reports, ensuring alignment with industry regulations and internal guidelines. Audit: - Assist the manager in preparing for and attending audits by external bodies, providing necessary documentation and information to demonstrate compliance and excellence. Quality: - Maintain and improve quality standards by verifying and reviewing procedures, ensuring strict adherence to company and regulatory requirements. Employee management: - Lead the team by setting clear goals, recognizing achievements, and identifying training and development needs to foster a motivated and high-performing workforce. Requirements and qualifications: - Bachelor’s degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, or Chemical Engineering. - In-depth knowledge of cGMP, pharmaceutical processes, equipment, and utilities validation, particularly in bioprocessing and mRNA requirements. Professional experience: - Minimum of 5 years’ experience in equipment and utilities validation with a proven track record in a sterile pharmaceutical environment. Languages: - Proficient in English. Personality: - Strong teamwork orientation. - Excellent technical documentation skills. - High attention to quality and detail. - Strong organizational and management capabilities. Desirable: - Technical/engineering expertise in production facilities for lyophilized drugs, sterile liquids, or oral solids. - Experience in personnel management.