Description
Position Description and Responsibilities
The Process Validation engineer will be responsible for the planning and execution of Process Validation and Process Validation Support studies at J&J facilities. The Individual will also be expected to provide support and leadership to Technology Transfer activities.
Primary Tasks and Responsibilities
- The role will involve the identification and analysis of available information required for Process Validation/Process Validation Support studies within J&J operations.
- Will be expected to plan and execute studies in association with Operations, QC, and Engineering personnel from J&J.
- Provide Technical support and leadership for Technology Transfer Teams.
- Provide support and technical input to regulatory submissions and filings.
- Plan & Implement Process Validation/Pro Val Support Studies
Experience and Education
- Experience of working in an EU/FDA regulated environment.
- Substantial experience of drafting plans & protocols and executing Validation support type studies in a Biotech environment. Of specific interest will be the areas of Cleaning Validation, Mixing Studies, Hold Studies, and the planning and implementation of Process Validation Batches.
- Bachelors degree qualification in science or engineering.
- Knowledge and experience of all relevant Environmental, Health and Safety regulations and guidelines.
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
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