Senior Validation Engineer– 12 months contract, Lausanne
Senior Validation Engineer– 12 months contract, Lausanne
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Lausanne, Schweiz
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Aufgegeben: vor weniger als einem Monat
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Merken
Anzeigentext
At Medtronic you can begin a life‑long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life The Senior Validation Engineer is responsible for leading and executing validation activities for equipment, processes, and systems in a high‑volume manufacturing environment. The role ensures sustained compliance with regulatory and quality requirements while supporting operational excellence.
A key aspect of the position is the technical leadership of validation activities during New Product Introduction (NPI) and ensuring a robust and compliant design transfer into manufacturing.
Responsibilities may include the following and other duties may be assigned:
Lead validation activities during New Product Introduction (NPI) and technology transfer to manufacturing
Define, own, and execute process validation strategies aligned with product, process, and regulatory requirements
Act as the validation subject‑matter expert during design transfer phases
Partner with R&D to ensure Design for Manufacturability (DfM) and validation readiness early in development
Review product designs, specifications, and manufacturing processes to ensure robustness and compliance
Lead the development and execution of validation deliverables, including:
Process validation (IQ/OQ/PQ)
Equipment and system qualification
Test method validation (where applicable)
Ensure effective and compliant design transfer through:
Risk management activities (e.g., FMEA)
Process characterization and capability studies
Complete, audit‑ready documentation aligned with regulatory expectations
Support and lead pilot builds, engineering runs, and ramp‑up to high‑volume production
Proactively identify, assess, and mitigate technical and validation risks to ensure successful product launches
Serve as the validation technical authority for manufacturing operations
Lead investigations for validation‑related deviations, CAPAs, and change controls
Ensure processes and systems remain in a validated state throughout their lifecycle
Support continuous improvement initiatives while maintaining compliance
Required Knowledge and Experience
Bachelor’s or master’s degree in engineering or related field (e.g., HEIG-VD, HES‑SO, or equivalent)
7+ years of experience in validation, manufacturing engineering, or quality in a regulated industry
Strong experience with lifecycle management (IQ/OQ/PQ)
Experience in MedTech or pharmaceutical manufacturing
Exposure to automated or high‑volume production environments
Solid understanding of GMP, ISO 13485, and regulatory expectations
Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits&Compensation Medtronic offers a competitive salary and flexible benefits package. Pay range: Switzerland: 111,200.00 CHF– 166,800.00 CHF.
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A Day in the Life The Senior Validation Engineer is responsible for leading and executing validation activities for equipment, processes, and systems in a high‑volume manufacturing environment. The role ensures sustained compliance with regulatory and quality requirements while supporting operational excellence.
A key aspect of the position is the technical leadership of validation activities during New Product Introduction (NPI) and ensuring a robust and compliant design transfer into manufacturing.
Responsibilities may include the following and other duties may be assigned:
Lead validation activities during New Product Introduction (NPI) and technology transfer to manufacturing
Define, own, and execute process validation strategies aligned with product, process, and regulatory requirements
Act as the validation subject‑matter expert during design transfer phases
Partner with R&D to ensure Design for Manufacturability (DfM) and validation readiness early in development
Review product designs, specifications, and manufacturing processes to ensure robustness and compliance
Lead the development and execution of validation deliverables, including:
Process validation (IQ/OQ/PQ)
Equipment and system qualification
Test method validation (where applicable)
Ensure effective and compliant design transfer through:
Risk management activities (e.g., FMEA)
Process characterization and capability studies
Complete, audit‑ready documentation aligned with regulatory expectations
Support and lead pilot builds, engineering runs, and ramp‑up to high‑volume production
Proactively identify, assess, and mitigate technical and validation risks to ensure successful product launches
Serve as the validation technical authority for manufacturing operations
Lead investigations for validation‑related deviations, CAPAs, and change controls
Ensure processes and systems remain in a validated state throughout their lifecycle
Support continuous improvement initiatives while maintaining compliance
Required Knowledge and Experience
Bachelor’s or master’s degree in engineering or related field (e.g., HEIG-VD, HES‑SO, or equivalent)
7+ years of experience in validation, manufacturing engineering, or quality in a regulated industry
Strong experience with lifecycle management (IQ/OQ/PQ)
Experience in MedTech or pharmaceutical manufacturing
Exposure to automated or high‑volume production environments
Solid understanding of GMP, ISO 13485, and regulatory expectations
Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits&Compensation Medtronic offers a competitive salary and flexible benefits package. Pay range: Switzerland: 111,200.00 CHF– 166,800.00 CHF.
#J-18808-Ljbffr
Highlights
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FirmennameMedtronic
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JobtitelSenior Validation Engineer– 12 months contract
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