Process Engineer
3 days ago
Roles & Responsibilities Support Computer System Validation (CSV)activities for QC lab systems, including benchtop instruments and associated software (e.g., Empower, LabX, Chromeleon, LabSolutions, etc.).Develop and execute IQ, OQ, PQ protocols, test scripts, and validation reports in line with site and corporate procedures.Prepare and maintain validation documentation — URS, Risk Assessments, Traceability Matrix, Summary Reports, and Validation Plan.Provide technical and validation supportfor instrument installation, configuration, and qualification.Ensure all systems and documentation comply with GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity (ALCOA+) standards.Collaborate with QA, IT, and Laboratoryteams for change control, deviation management, and system lifecycle maintenance.Participate in system reviews, backup and restore verification, and access control management for validated systems.Maintain audit-ready documentation and support internal or regulatory inspections.Qualifications & Requirements:Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline.3–6 years of experience in Computer System Validation (CSV), Benchtop IT, preferably supporting QC / analytical laboratories.Hands-on experience in test case drafting and execution, validation report preparation, and QA review coordination.Exposure to benchtop instrument qualification and validation (HPLC, GC, TOC, Balances, etc.) and related software.Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity requirements. To apply, simply click the "Apply" button EA Licence No: 25S3131 Tell employers what skills you have FTIRHPLCGMPRaw MaterialsChemistryComplianceLIMSPackagingAnalytical TechniquesRegulatory RequirementsUVLaboratoryAudit
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