Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
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.