Ms&t Director - Sterile Technical Sme (Isolators - Vhp)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fqvnb

**Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Office **Position Summary**:
Join our distributed technical team specializing in Isolator Technology on a full-time remote basis. Provide expertise in Isolator Technology, aseptic pharmaceutical processes, and process technologies. **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.** **Key Responsibilities**:
Manufacturing Support
- Provide SME expertise in Isolator Technology for pharmaceutical processes - help establish division strategy, develop global standards, and drive harmonization within the DPD sterile sites.
- Offer significant expertise on common topics related to Isolator Technology, including Decontamination Cycles, Environmental Monitoring, and Cycle Development.
- Support sites in troubleshooting/root cause investigations by providing second-level specialist expertise and harmonizing related technical processes across units.
- Review sterile site aseptic practices and set plans for improvements.
- Collaborate with sterile manufacturing site Teams to successfully implement new technologies and ensure timely product launches.




- Continuously monitor GMP, EU, and FDA regulatory changes and requirements.
- Provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization; facilitate IQ, OQ, and PQ equipment and process qualifications upon request. **Stewardship for Aseptic Network & New Product Launch**: - Act as the Network SME for collaborating with Local and global MSAT networks to define and implement new technical standards.
- Ensure internal and external benchmarking to stimulate and extend knowledge, growing know-how among associates.
- Author and implement GOPs for assigned technologies. **Qualifications and Requirements**: - MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field.
- 10+ years of professional experience in GMP manufacturing relevant to the specialist area of expertise.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
- Up to 30-40% travel, as needed.
- Confident communicator both verbally and in writing.
- Ability to influence others and build cross-functional teams while setting clear business objectives.
- Demonstrated leadership and technical experience.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fqvnb