**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.

📌 Equipment Validation Compliance Team Leader (Monza)
🏢 Thermo Fisher Scientific
📍 Monza