Associate Validation Engineer
Amneal • Piscataway Township, NJ3d
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Associate Validation Engineer
Amneal•Piscataway Township, NJ
About The Position
The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements.
Requirements
- Compliance to cGMP and Amneal's quality requirements
- Ability to assist in the preparation/execution of Installation Qualification(IQ)/Operational Qualification(OQ)/Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software.
- Ability to help generate qualification report and help summarize the results.
- Ability to perform re-qualification of equipment, facility and utilities as required under supervision.
- Ability to identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution.
- Ability to draft Standard Operating Procedure(SOP) for new operational equipment.
- Ability to support process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service.
- Ability to work with equipment vendors to collect equipment manual and other required documents.
- Ability to closely work with the maintenance & facility teams to complete new equipment installation as per project requirement.
- Ability to assist with engineering projects and performs other duties as assigned.
Responsibilities
- Assist in the preparation/execution of Installation Qualification(IQ)/Operational Qualification(OQ)/Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor.
- Performs re-qualification of equipment, facility and utilities as required under supervision.
- Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution.
- Draft Standard Operating Procedure(SOP) for new operational equipment.
- Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service.
- Works with equipment vendors to collect equipment manual and other required documents.
- Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.
- Assist with engineering projects and performs other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
Job Search Resources
Career Resources
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