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
Boston, MA
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