Validation Engineer - PharmaceuticalThe International Society for Pharmaceutical Engineering, Inc. • Durham, NC, US
Validation Engineer - Pharmaceutical
The International Society for Pharmaceutical Engineering, Inc. • Durham, NC, US
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job_description.job_card.job_descriptionBachelor of Science degree (or equivalent) and 7 + years in a pharmaceutical cGMP environment is required. A combination of experience and / or education will be taken into consideration. Must possess a working knowledge of Pharmaceutical validation and cGMP concepts.
2531 Validation Engineer - Pharmaceutical
Our client is a Fortune 500 Pharmaceutical Company with Global reach. They are currently looking for a strong Validation Engineer to join their tenured Validation team.
Key responsibilities
- Provide direction, reviews and provides Quality approval for design qualification documents, validation protocols, summary reports, discrepancy reports and CPV reports.
- Provide the Quality Assurance review and approval of Engineering, Calibration, Facility Maintenance, Production Support (Maintenance), Technical Services and IT procedures and forms.
- Authors protocols and reports as required / assigned.
- Perform validation planning and tracking.
- Assist in the development and maintenance of the procedures defining the validation program at MTI.
- Participates in the evaluation of changes to validated systems to ensure the validate state is maintained. Provides direction, reviews and approves proposed changes and facilitates decision making regarding the extent of any re-validation requirements.
- Assist in the compilation of periodic reports required by the validation program.
Minimum qualifications
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Validation Engineer • Durham, NC, US
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