MS&T Director – Sterile Technical SME (Visual Inspection)
Descrizione dell'offerta
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 & 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 improving the 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.