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.
Numbers & Facts
Location
Newark, NJ
Description
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.