Validation Engineer

Yoh has a six (6) month contract opportunity for a VALIDATION ENGINEER to join our client in Phoenix, Arizona.

JOB RESPONSIBILITIES:

- Responsible for conducting QA review and approval of Validation, Engineering and Quality Control protocols, procedures, test plans and summary reports.
- This responsibility includes IQ/OQ/PQ, method validation approvals and conducting data integrity audits.
- Responsible for QA review and approval of change control requests (eg, DCRs, CCRs) to ensure the proposed changes are justified, supported by data and have been appropriately validated where applicable.
- Performs technical assessments and QA approval of equipment purchases, facility modifications, and engineering changes in accordance with cGMP (eg, review and approval of design specifications, drawing revisions, and change requests).
- Provides QA support for process and product re-engineering.
- Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensures they are resolved in a compliant manner.
- Responsible for QA review and approval of preventive maintenance deviations and calibrations out of tolerance investigations.
- Responsible for QA review and approval of materials and products to include commercial product review and release.
- Responsible for QA review and release of in-process and finished product.
- Perform other duties as necessary to ensure the efficient and effective operation of the department.

JOB QUALIFICATIONS:

- Experience with development and execution of equipment IQ/OQ/PQ protocols.
- Autoclaves (Cycle development).
- Must have experience with Kaye Validator.
- Filling Line - Vial Washers, Depyrogenation Tunnels, Fillers - Aseptic.
- Automated Loading Systems.
- Lyophilizers.
- Fill Finish Equipment - Capper, External Vial Washer, and Coder.
- Packaging and Inspection - Semi-automated inspection/presentation systems, vision systems, Cartoner and Labeler.
- Five plus (5 +) years of experience.

DISCOVER ALL THAT\'S POSSIBLE WITH YOH. APPLY NOW.

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources .

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