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

Position Overview

• Location Type: Remote (EU/US)
• Preferred Locations: Italy (Monza & Ferentino), UK (Swindon), North Carolina (US) (Greenville), France (Bourgoin)
• Job Type: Full time
• Work Schedule: Standard Office Hours (40/wk)
• Environmental Conditions: Office
• Salary: Not Specified

This role is for a Global Technical Subject Matter Expert (SME) in Visual Inspection at Thermo Fisher Scientific, focusing on improving visual inspection processes globally within the DPD sterile sites.

Key Responsibilities

Manufacturing Support

• Provide expertise in visual inspection for pharmaceutical processes.
• Assist in strategy creation and set global standards for visual inspection.
• Ensure consistency in DPD sterile sites' visual inspection practices.
• Offer significant expertise on common Visual Inspection (VI) technologies/equipment (Manual/Semi-automatic/Automatic) and Leak Detection systems.
• Possess knowledge of AI applications to AVI, including recipe creation/optimization and validation support.
• Perform process characterization of related pharmaceutical processes to enhance robustness and sustainability.
• Support sites in troubleshooting and root cause investigations by providing second-level specialist expertise.
• Harmonize related technical processes across units.
• Review sterile site aseptic practices and establish improvement plans.
• Collaborate with sterile manufacturing site teams for efficient new technology implementation and 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.
• Identify and drive improvement opportunities to enhance process effectiveness, product quality, and operating efficiency.
• Support the development of Training Curricula for Site SMEs and ensure 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.
• Establish technical standards for current and upcoming technologies and equipment.
• Conduct internal and external benchmarking to stimulate knowledge sharing.
• Grow associates' know-how and spread it across the organization.
• Author and implement GOPs (General Operating Procedures) 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).
• Ability to travel up to 30-40%, as needed.
• Confident communicator, both verbally and in writing.
• Ability to influence others and build cross-functional teams while setting clear business objectives.
• Proven leadership and technical experience.