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Validation Engineer

$98.57k

Unicon Sciences Inc.

Minimum Education Required

Master's degree

Compensation

$98,571.00 - $98,571.00 / Yearly

Hours Per Week

40

Number Of Positions

5

Shift

First Shift (Day)

Job Description

Analyze validation test data to determine whether processes or equipment have met validation criteria and identify root causes of problems for various pharma and regulated facilities in compliance with GxP and GAMP 5 requirements. Prepare IQ/OQ/PQ validation and performance qualification protocols for new or modified processes, computerized equipment, or manufacturing workflows across various production environments. Coordinate the implementation and scheduling of validation testing with affected departments while supporting CAPA processes and UAT execution. Create, populate, and maintain databases for tracking validation activities and test results. Perform risk assessments using FMEA methodologies and support 21 CFR Part 11 and Data Integrity compliance. Master’s degree in Science, Regulatory Affairs, Pharmaceutical Science, Management, Pharmacy, Chemistry, Biochemistry, Engineering, Biology, or a related life sciences discipline is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.

Email Resume to HR Dept., Unicon Sciences, Inc., at View email address on click.appcast.io.

Place of Work

On-site

Requisition ID

VE854

Job Type

Full Time

Application Email

View email address on click.appcast.io

Vacancy posted 3 days ago
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