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Senior Technical Sub-Project Manager Packaging & Assembly(m/w/x)
Technical leadership for automated assembly and packaging lines at global healthcare company. Management of complex, multidisciplinary projects required. Shift work, 4-day work week.
Anforderungen
- Highly disciplined technical leadership
- Strong sense of accountability
- Management of complex, multidisciplinary projects
- Exceptional problem-solving skills
- Analytical mindset for technical issue resolution
- Effective communication for stakeholder alignment
- Effective leadership of external partners
- Bachelor’s Degree in Mechanical Engineering, Mechatronics, or related technical discipline
- Expertise in collaborating with equipment manufacturers
- Expertise in executing FAT/SAT
- Expertise in managing commissioning and qualification activities
- Profound knowledge of regulatory requirements (FDA, EMA, GMP)
- Profound knowledge of standards for combination products (ISO 13485, EU MDR)
- Ability to execute complex scopes in investment projects
- Willingness to travel (50% or more)
- Readiness for international assignments of 1 to 3 years
Aufgaben
- Provide technical leadership for automated manufacturing systems
- Lead planning, design, and procurement of assembly and packaging lines
- Manage project lifecycle from concept to commercial ramp-up
- Oversee sub-project budgets, schedules, and resource planning
- Align with stakeholders and project management team
- Act as primary technical and commercial interface for suppliers
- Drive engineering for state-of-the-art assembly systems
- Lead packaging system projects for traceability and data integrity
- Define and execute qualification strategies
- Ensure compliance with ISO 13485, EU MDR, EU GMP, FDA CFR 21, and GAMP 5
- Serve as technical SME during regulatory inspections and audits
Berufserfahrung
- 8 - 12 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
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Senior Technical Sub-Project Manager Packaging & Assembly(m/w/x)
Technical leadership for automated assembly and packaging lines at global healthcare company. Management of complex, multidisciplinary projects required. Shift work, 4-day work week.
Anforderungen
- Highly disciplined technical leadership
- Strong sense of accountability
- Management of complex, multidisciplinary projects
- Exceptional problem-solving skills
- Analytical mindset for technical issue resolution
- Effective communication for stakeholder alignment
- Effective leadership of external partners
- Bachelor’s Degree in Mechanical Engineering, Mechatronics, or related technical discipline
- Expertise in collaborating with equipment manufacturers
- Expertise in executing FAT/SAT
- Expertise in managing commissioning and qualification activities
- Profound knowledge of regulatory requirements (FDA, EMA, GMP)
- Profound knowledge of standards for combination products (ISO 13485, EU MDR)
- Ability to execute complex scopes in investment projects
- Willingness to travel (50% or more)
- Readiness for international assignments of 1 to 3 years
Aufgaben
- Provide technical leadership for automated manufacturing systems
- Lead planning, design, and procurement of assembly and packaging lines
- Manage project lifecycle from concept to commercial ramp-up
- Oversee sub-project budgets, schedules, and resource planning
- Align with stakeholders and project management team
- Act as primary technical and commercial interface for suppliers
- Drive engineering for state-of-the-art assembly systems
- Lead packaging system projects for traceability and data integrity
- Define and execute qualification strategies
- Ensure compliance with ISO 13485, EU MDR, EU GMP, FDA CFR 21, and GAMP 5
- Serve as technical SME during regulatory inspections and audits
Berufserfahrung
- 8 - 12 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
F. Hoffmann-La Roche AG
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
Noch nicht perfekt?
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