Process Validation Engineer (all genders)

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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

Primary Duties

The individual will be expected to provide process validation support for Takeda vaccines manufacturing operations located in internal and CMO manufacturing locations. The process validation activities related to the vaccine manufacturing sites include, but are not limited to, the following areas:

• Validation subject matter expert to conceive, design and direct the execution of validation/technical shared services projects in support of VBU.
• Oversight of Process Validation activities including development, facilitation, and support of strategies for process validation and related activities/documentation for Drug Substance, Drug Product and Diluent manufacturing processes for Lifecycle Validation Stages.
• Authoring process validation documentation for Lifecycle Process Validation.
• Oversight/support of process validation activities, as well as perform data analysis and compilation of data and results into summary and final reports.
• Align manufacturing processes with executed validation 
• Participate in regulatory inspections.
• Identify opportunities for continuous improvements, participate in the deployment of best practices, represent process validation at Singen & CMO Work System meetings and support/maintain the process validation communications board and community of practice.
• Establish, support and direct collaborative projects with other VBU functions (e.g. CMC, External Manufacturing, PO, Quality) and External Partners (CMOs) to generate and execute process / product technology transfers and the associated qualification/validation activities.

Oversight including developing, and authoring strategy and/or execution documents for Process Validation activities in the following areas:

• Tech transfer (new product introduction)
• Change management
• Continuous lifecycle management

Develop and assess the following Quality System elements for Process Validation:

• CAPAs
• Deviations

Participate and contribute in design, development, validation, and routine GMP activities:  

• Provide technical input to validation activities
• Represent process validation during tech transfer activities as required.
• Represent process validation during site GMP activities and participate on cross-functional teams
• Support process validation Quality Systems

Identify opportunities for personal and professional development, continuous improvements, participate in the deployment of best practices, represent MS&T Validation at various project and commercial meetings and support/maintain the process validation communications board. 

• Participate in regulatory activities including inspections and filing for Process Validation.
• Train other executing staff on validation protocols as applicable.

Education and Experience Requirements

Internal and External Contacts

Other Job Requirements

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time