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

Location: Remote (EU/US)

Preferred Locations:

Italy: Monza & FerentinoUK: SwindonNorth Carolina (US): GreenvilleFrance: 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 sitesOffer significant expertise on common VI technologies/equipment (Manual/Semi-automatic/Automatic) and Leak Detection systemsKnowledgeable about AI application to AVI (e.g., recipes creation/optimization, support to validation)Perform process characterization of related pharmaceutical processes to increase robustness and sustainabilitySupport sites in troubleshooting/root cause investigation by providing second-level specialist expertise and harmonizing related technical processes across unitsReview sterile site aseptic practices and set a plan for improvements and adaptationsWork closely with sterile manufacturing site teams to efficiently implement new technologies and ensure timely product launchesMonitor GMP, EU, and FDA regulatory changes and requirements, review industry-specific journals and periodicalsSupport projects requiring expertise in aseptic manufacturing and lyophilization technologyProvide technical support in aseptic manufacturing, validation, new technologies, and sterilization; facilitate IQ, OQ, and PQ equipment and process qualifications upon requestIdentify and drive opportunities for improvement, suggesting ways to improve process effectiveness, product quality, and operating efficiencySupport the development of Training Curriculum for Site SMEs and assure alignment across sitesProvide 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 organizationAuthor and implement GOPs for assigned technologies

Qualifications and requirements

MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific fieldSignificant career experience in GMP manufacturing relevant to the specialist area of expertiseValidated process understanding (Pharma, GMP, Regulatory aspects)Up to 30-40% travel, as neededConfident communicator both verbally and in writingAble to influence others and build cross-functional teams while setting clear business objectivesProven leadership and technical experience