Validation Engineer
Validation Engineer
Posted on :
06-10-2024
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Job Description
Validation Engineer
Location:TucsonAZ (100% onsite)
Duration:12 months extendable
Location:TucsonAZ (100% onsite)
Duration:12 months extendable
The Validation Engineer will be responsible to ensure that validation requirements are met for all existing and new equipment/ facilities/utilities and processes by preparing and executing detailed validation protocols that meet the relevant testing standards and any requirements.
Must have QUALIFICATIONS:
- Validation Protocol Development and Execution: Expertise in creating and executing validation protocols (IQ OQ PQ CSV etc.).
- Regulatory Compliance Knowledge: Strong understanding of FDA cGMP GAMP and related regulatory standards.
- Technical ProblemSolving: Ability to troubleshoot and resolve technical issues during validation.
- CrossFunctional Collaboration: Effective communication and coordination with internal teams and external suppliers.
- Documentation Management: Proficiency in managing validation documents databases and SOPs.
Responsibilities:
- Designs and drafts validation sampling and testing plan/protocols.
- Executes and reports on validation studies such as Process Validation Cleaning Validation CSV Commissioning IQ OQ and PQ studies.
- Resolve technical issues encountered during study execution.
- Track and expedite the review and signoff of qualification documentation.
- Support execution of validation activities.
- Interact with individuals from different departments to plan execute and complete qualification activities.
- Drive the completion of validation efforts according to deadlines.
- Write / guide the writing of departmental procedures required for validation.
- Assist during internal and 3rd party audits wrt validation requirements.
- Initiate CAPAs NCRs and Change Requests where required and assist with investigations.
- Assist with identifying maintenance and calibration requirements.
- Coordinate suppliers wrt Validation activities including obtaining quotes from suppliers.
- Validation administration such as updating the validation plan maintaining databases standard referencing of documentation.
- Review Validation plans protocols and SOPs written by other validation team members.
- Manage workload arising from unscheduled events.
- Other duties as assigned by management.
Employment Type
Full Time
Key Skills
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