Sr. Specialist, Engineering (M/F/D)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ihjzh

OverviewIn this role you will provide technical leadership and support for the global external manufacturing of commercial sterile drug products.
You will partner with contract manufacturers and internal Technical Operations to ensure state-of-the-art processes, drive transfers, and manage investigations and CAPAs.
The position offers exposure to senior management and opportunities to lead cross-functional teams on strategic external manufacturing initiatives.
You will apply your expertise to maintain compliant, robust manufacturing operations and enable successful regulatory inspections.
Retribuzione / Benefitsannual premio
long-term incentives
hybrid work arrangements
benefits (unspecified)
competitive compensation
occupational healthcare
ResponsabilitàLead technical issues for global external manufacturing of commercial Drug Product
Provide technical leadership for sterile drug product management within Technical Operations
Support technical transfers of new sterile drug products to contract manufacturing sites
Drive internal and external changes to implement advanced technologies and processes
Lead day-to-day technical activities including troubleshooting, process changes,



and new technology implementation
Serve as primary interface on technical matters between Technical Operations and third-party drug product manufacturers
Provide leadership on Change Controls, investigations, CAPAs, and support for Health Authority Inspections
Lead critical technical projects related to manufacturing of commercial sterile drug product
Organize cross-functional teams to manage investigations and CAPA/change control implementations
Coordinate risk assessments and develop innovative solutions for complex issues
Requisiti fondamentaliBachelor's degree in engineering, biological/chemistry sciences or related discipline
7+ years in manufacturing (process startup, routine manufacturing, and/or technical transfer)
3+ years in sterile/aseptic Drug Product processing including formulation and filling
Experience in Relationship Management
Cross-functional collaboration
Strong communication skills
Multitasking under tight deadlines
GMP knowledge
Change Control processes
Drug Product Manufacturing validation

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ihjzh