Senior Software Engineer developing embedded software platforms for Infotainment and Software Defined Vehicle solutions at GM. Leading design and integration efforts for Android/QNX/Embedded Linux systems.
About the role
- Global Technical Leader for sterile biotech products at Chiesi ensuring technical robustness throughout product lifecycle. Leading industrialization strategy and lifecycle management projects in a collaborative environment.
Responsibilities
- act as the global technical reference for sterile biotech products
- ensure technical robustness throughout the product lifecycle
- deliver innovative, compliant solutions supporting the business and Quality organization
- contribute to the definition and execution of the industrialization strategy for new products within the R&D Product Teams
- structure, plan, and coordinate industrial process validation activities
- provide technical leadership for lifecycle management projects concerning established products
- oversee the technical assessment and implementation of modifications to critical components
- lead and oversee Technology Transfer activities from R&D or external partners
- coordinate Product Technical Teams and/or contribute to cross-functional workstreams
- review and approve technical protocols and reports
- support Program Managers in preparation of key deliverables and updates for governance bodies
- collaborate with Virtual Plant Managers and Procurement
- perform product Sustainability Assessments and define improvement plans
Requirements
- Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field
- 10+ pharmaceutical/biotech industry years in drug product manufacturing
- experience in aseptic processing
- fluency in written and verbal communication in English
- willingness to travel up to 30%
- experience working in multicultural and multinational environments preferred
- experience working within a CRO or CMO environment preferred
- demonstrated strength in project management, problem-solving, and interpersonal communication
- solid understanding of the pharmaceutical industry and end-to-end Biotech sterile products manufacturing
- experience in pharmaceutical or biotech MSAT process development and/or GMP manufacturing preferred
- strong working knowledge of current regulations, quality expectations, and industry trends
Benefits
- comprehensive healthcare programs
- work-life balance initiatives
- robust relocation support
- competitive salary package
- performance bonuses
- flexible working arrangements
- remote work options
- tax assistance services for foreign colleagues
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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