Job summary:
We are seeking an experienced Validation Specialist to support validation activities in a GMP-regulated environment. Roles and Responsibilities:
10 years of experience in Validation within Pharma, Biotech, or Life Sciences.
Hands-on experience with IQ, OQ, and PQ.
Experience with equipment, facility, utility, or process validation.
Strong knowledge of GMP, GxP, and FDA regulations.
Experience developing and executing validation protocols and reports.
Experience with deviations, CAPA, change controls, and risk assessments.
Experience supporting FAT/SAT, commissioning, and qualification activities.
Strong technical writing and documentation skills.
Ability to work with Engineering, Quality, Manufacturing, and Validation teams.
Numbers & Facts
Location
Newark, NJ
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Commissioningunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Manufacturingunmatched
Process Validationunmatched
Risk Analysisunmatched
Risk Managementunmatched
Technical Writingunmatched
Validation Planunmatched
Writing Skillsunmatched
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