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Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Position: MS&T Director – Sterile Technical SME (Visual Inspection)

Reports To: DPD Division MSAT Head

Preferred Locations:

+ **Italy** : Monza & Ferentino

+ **UK:** Swindon

+ **North Carolina** **(US)** : Greenville

+ **France** : Bourgoin

These locations are key sites for our operations

POSITION SUMMARY

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

+ Knowledgeable about AI application to AVI (e.g., recipes creation/optimization, support to validation)

+ 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.