Validation Specialist Katalyst Healthcares & Life Sciences - 4.0 Newark, NJ Job Details Contract 1 day ago Qualifications Quality control corrective actions Content creation for technical audiences Technical documentation Pharmaceutical regulatory compliance Preventive action implementation Technical writing experience within manufacturing Production deviation management Quality control preventive actions Corrective and preventive actions (CAPA) GMP Production validation processes Pharmaceutical company experience Quality assurance experience within pharmaceutical industry Collaboration with manufacturing teams Commissioning phase involvement Senior level Risk assessment implementation FDA regulations Pharmaceutical manufacturing facility experience 10 years Full Job 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.