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Urgent! Commissioning and Qualification Specialist Job Opening In Rico – Now Hiring Technical & Engineering Consulting

Commissioning and Qualification Specialist



Job description

 Summary

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.


Responsibilities




  • Lead 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.




Requirements




  • Bachelor'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.


Required Skill Profession

Engineers



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