Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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. 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. J-18808-Ljbffr