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Validation Engineer
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Job Summary: The incumbent will independently lead validation activities for assigned equipment, processes, and computerized systems within a pharmaceutical facility.
Responsibilities:
. Develop and execute validation protocols(IQ/OQ/PQ, process validation, cleaning validation) and author final reports
. Lead validation risk assessments and ensurecompliance with GMP/GAMP requirements
. Investigate validation-related deviations andsupport CAPA implementation
. Coordinate validation activities withcross-functional teams (QA, Engineering, Manufacturing)
. Maintain and update validation master plans
Requirements:
. Degree in Engineering, Life Sciences, or related field
. At least 4 to 7 years of validation experience in pharmaceutical/biotech manufacturing
Contract: 12 months, subject to renewal based on performance
Job ID: 152904265
Skills:
commissioning and qualification activities, Kneat, single-use technologies, Biopharmaceutical processes, GMP Validation
Skills:
equipment qualification, validation lifecycle maintenance, Technical Writing, validation strategies, Cleaning Validation, Regulatory Submissions, Root Cause Analysis, technical execution of validation tasks
Skills:
computerized system validation , 21 Cfr Part 11, Test Scripts, risk assessments, validation documentation, GAMP 5, Validation Plans, Gmp, FAT SAT commissioning, IQ OQ PQ protocols, Capa
Skills:
Gamp, Validation Lifecycle Management, Cleaning Validation, Process Validation, Validation Management, Gmp, Computerised System Validation, Capa
Skills:
IQ OQ PQ, DeltaV CSV, FDA 21 CFR Part 11, validation documentation, GAMP 5, EU Annex 11, GMP Data Integrity, FAT SAT
