Process Validation Engineer
Posted on Feb 14, 2019 by Elevate Direct
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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