Job SummaryWe are seeking an experienced Subject Matter Expert (SME) in Purified Water (PW) Systems and Clean Steam Generators (CSG) to support the implementation, commissioning, qualification, and Computer System Validation (CSV) of new utility systems at a regulated manufacturing site. The ideal candidate will bring deep technical expertise in system design, instrumentation, and testing, ensuring full compliance with GMP, FDA, and international regulatory requirements. Key ResponsibilitiesLead and oversee the design, implementation, and start-up of new PW and CSG systems, ensuring alignment with project requirements and GMP standards.
Support commissioning and qualification (IQ, OQ, PQ) activities, including protocol development, execution, and documentation. Provide expert input and hands-on support in Computer System Validation (CSV) related to system instrumentation, control systems, and associated software. Review and approve functional specifications, design documentation, and validation deliverables. Collaborate with cross-functional teams (Engineering, QA, CSV, Automation, Operations) to ensure smooth project execution and issue resolution. Participate in risk assessments, gap analyses, and provide recommendations for system improvements. Support and guide instrumentation and testing strategies, including calibration, alarm verification, and performance testing.
Ensure systems meet compliance with FDA, EU Annex 1, ISPE, GAMP 5, and 21 CFR Part 11 requirements. Required QualificationsBachelor's degree in Engineering or related technical discipline. Minimum 5 years of experience with purified water and clean steam systems in regulated environments. Proven expertise in new system implementation, including commissioning, qualification, and CSV lifecycle. Strong knowledge of process instrumentation, control systems, and clean utility testing methodologies. Familiarity with industry standards such as ISPE Baseline Guides, USP, and ASTM E2500. Excellent documentation and technical writing skills. Bilingual (English/Spanish). Preferred SkillsExperience working in FDA-audited pharmaceutical facilities. Understanding of automation platforms (e. g.
, Honeywell BMS) and integration with utility systems. Ability to manage multiple priorities and interface with stakeholders at all levels.
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