Commissioning and Qualification Specialist
Technical & Engineering Consulting
- Manatí, PR
- Autónomo
- Tiempo completo
We are currently looking for skilled Commissioning and Qualification Specialist to support equipment qualification and system validation initiatives within a pharmaceutical laboratory setting. The role involves close coordination with departments such as Quality Control, Engineering, CSV/IT, and Lab Management to ensure all activities are executed in alignment with regulatory requirements and internal standards.ResponsibilitiesLead commissioning and qualification processes for laboratory instruments, including Vision and Keyence systems.Conduct IOQ (Installation and Operational Qualification) protocols and support Computer System Validation (CSV) efforts.Assist in creating and revising forms, standard operating procedures (SOPs), and related documentation.Work cross-functionally with QC, IT, Engineering, Technical Services, and QA teams.Provide consistent progress updates to the Project Engineering group.RequirementsBachelor's degree or higher in Chemistry, Biology, Microbiology, Engineering, Computer Science, or a related field.At least 3 years of hands-on experience in validating computerized systems in pharmaceutical laboratories or manufacturing environments.Solid understanding of validation processes, including PLCs and industrial computer systems.In-depth knowledge of regulatory frameworks such as cGMP, GAMP, SDLC, 21 CFR Part 11, and Data Integrity principles.Skilled in using MS Project, Visio, Adobe Acrobat, and the Microsoft Office suite.Prior experience with instrument qualification and method setup/configuration.Strong ability to write technical documentation clearly and accurately.