MS&T Director - Sterile Technical SME (Isolators - VHP)
MS&T Director - Sterile Technical SME (Isolators - VHP)
Posted on :
26-05-2025
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1 Vacancy
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Job Description
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.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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