**Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Office Position: MS&T; Director - Sterile Technical SME (Visual Inspection) **Reports To: DPD Division MSAT Head**:
**Location: Remote (EU/US)** **Preferred Locations**: - ** Italy**: Monza & Ferentino
- ** UK**: Swindon
- ** North Carolina** **(US)**: Greenville
- ** France**: Bourgoin These locations are key sites for our operations *** Work for Thermo Fisher Scientific as a Global Technical SME in Visual Inspection. Contribute to improve visual inspection process globally. **Key responsibilities**:
Manufacturing Support: - Offer expertise in visual inspection for pharmaceutical processes, assist in strategy creation, set global standards, and ensure consistency in DPD sterile sites
- Offer significant expertise on common VI technologies/equipment (Manual/Semi-automatic/Automatic) and Leak Detection systems
- Perform process characterization of related pharmaceutical processes to increase robustness and sustainability
- Support sites in troubleshooting/root cause investigation by providing second-level specialist expertise and harmonizing related technical processes across units
- Review sterile site aseptic practices and set a plan for improvements and adaptations
- Work closely with sterile manufacturing site teams to efficiently implement new technologies and ensure timely product launches
- Monitor GMP, EU, and FDA regulatory changes and requirements, review industry-specific journals and periodicals

- Support projects requiring expertise in aseptic manufacturing and lyophilization technology
- Provide technical support in aseptic manufacturing, validation, new technologies, and sterilization; facilitate IQ, OQ, and PQ equipment and process qualifications upon request
- Identify and drive opportunities for improvement, suggesting ways to improve process effectiveness, product quality, and operating efficiency
- Support the development of Training Curriculum for Site SMEs and assure alignment across sites
- Provide training and education on related technologies to site employees **Stewardship for Aseptic Network & New Product Launch**: - Serve as the Network SME, collaborating with local and global MSAT networks to establish technical standards for current and upcoming technologies and equipment.
- Assure internal and external benchmarking to stimulate knowledge, growing associates' know-how and spreading it across the organization
- Author and implement GOPs for assigned technologies **Qualifications and requirements**: - MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field
- Significant career experience in GMP manufacturing relevant to the specialist area of expertise
- Validated process understanding (Pharma, GMP, Regulatory aspects)
- Up to 30-40% travel, as needed
- Confident communicator both verbally and in writing
- Able to influence others and build cross-functional teams while setting clear business objectives
- Proven leadership and technical experience

Ms&t Director - Sterile Technical Sme (Visual Inspection)

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