Validation Engineer

We are seeking an experienced Validation Engineer to support commissioning, qualification, and computer system validation activities within a cGMP biopharmaceutical manufacturing environment. The ideal candidate will manage validation projects from concept through performance qualification while ensuring regulatory compliance and supporting manufacturing operations.Key Responsibilities:• Lead equipment, utility, facility, and computer system validation projects from planning through execution.• Author, review, and execute IQ/OQ/PQ protocols, validation reports, and lifecycle documentation.• Support Commissioning & Qualification (C&Q) and Computer System Validation (CSV) activities.• Validate bulk drug substance manufacturing equipment in single-use facilities.• Review URS, FS, DS, commissioning documents, and validation deliverables.• Support process improvements, temperature mapping, and compliance with cGMP/GxP requirements.• Collaborate with Engineering, Manufacturing, MSAT, QA, and cross-functional teams to ensure successful project execution.Required Qualifications:• Bachelor's degree in Engineering, Science, or a related field.• 5+ years of validation experience in biopharmaceutical or biotech manufacturing.• Strong experience with equipment qualification, CSV, IQ/OQ/PQ, and process validation.• Knowledge of cGMP, GxP, validation lifecycle, and regulatory requirements.• Experience with DeltaV, LIMS, MES, or similar validated systems preferred.• Excellent technical writing, communication, and problem-solving skills.