CSV Qualification Engineer, Phamaceutical

1 week ago

Singapore ALWAYSHIRED PTE. LTD. Full time

Responsibilities Configure and support Building Management Systems (Rockwell or equivalent) for pharma facilities. Perform and document qualification/validation activities (IQ, OQ, PQ) for BMS, HVAC, and utilities systems (e.g., cleanrooms, compressed air, WFI, chilled water). Troubleshoot and resolve system or process deviations during commissioning and validation. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and cGMP requirements. Prepare validation protocols, execute testing, and generate final reports. Support incident management and change control processes for validated systems. Collaborate with cross-functional teams (engineering, QA, regulatory, and project management) at client sites. Requirements Bachelor’s degree in Engineering, Science, or related field. Experience in one or more of the following: Pharma / Biotech / Medical Device industries (validation/qualification role). HVAC / Utilities / Facilities engineering (with cleanroom or GMP experience). Automation / Controls engineering (Rockwell, Siemens, Honeywell, or similar BMS/DCS platforms). Strong knowledge of validation methodology (IQ/OQ/PQ). Familiarity with pharma regulations (FDA, EMA, GAMP) is an advantage. Interested candidates please apply online or send your latest CV to AlwaysHired Pte Ltd Reg No: R EA: 24C2293We regret to inform that only shortlisted candidates will be notified. Please note that your response to this advertisement will constitute informed consent to the collection, use, and/or disclosure of personal data by AlwaysHired, its affiliates and, where necessary, to relevant third parties, for purposes such as job application processing, career advisory, research, and other administrative purposes, in compliance with the relevant provisions of the Privacy Policy available at #J-18808-Ljbffr

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