Validation Engineer

Unicon Sciences Inc.

South Plainfield, NJFull-time$99K/yrSeen 2 days agoSeen in employer's feed 2 days ago

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At a glance

Compensation

$99K/yr

Location

South Plainfield, NJ

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

The Validation Engineer analyzes validation test data and prepares IQ/OQ/PQ protocols for processes, equipment, and manufacturing workflows in pharma and regulated facilities. The role coordinates validation testing, supports CAPA and UAT, maintains validation tracking databases, and performs FMEA risk assessments. It supports compliance with GxP, GAMP 5, 21 CFR Part 11, and Data Integrity requirements. A master's degree in a specified or related life sciences discipline is required.

Skills & qualifications

RequiredNice to have

Skills

Validation Data AnalysisIQ/OQ/PQ ProtocolsValidation TestingCAPAUATDatabase MaintenanceFMEAGxP ComplianceGAMP 521 CFR Part 11Data Integrity

Qualifications

Master's Degree in Related Field

Full job description

Minimum Education Required

Master's degree

Compensation

$98,571.00 - $98,571.00 / Yearly

Hours Per Week

Number Of Positions

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 [email protected].