Katalyst CRO
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Validation Engineer
role at
Katalyst CRO . This position involves: Identifying, designing, and developing equipment related to new product introduction. Initiating Validation Master Plans for new projects. Developing manufacturing processes for new projects. Performing IQ, OQ, PQ protocol writing and validation activities. Studying existing processes to implement improvements on new products. Performing NPI prototyping and project phases. Managing specifications and activities of process/product validation. Managing projects through meetings, milestone tracking, and project planning. Communicating business issues or opportunities to management. Performing other duties as assigned. Requirements include a Bachelor's degree in Engineering, 3+ years of medical device NPI validation experience, proficiency with SolidWorks, knowledge of GMP, risk management, and familiarity with standards like ISO 13485 and FDA 21 CFR Part 820. Experience with ADAPTIV, Windchill PLM, and good communication skills in English are also required. This role is at an associate level, contract employment, within the pharmaceutical manufacturing industry, located in Irvine, CA, with salary ranges between $82,500 and $157,500.
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Validation Engineer
role at
Katalyst CRO . This position involves: Identifying, designing, and developing equipment related to new product introduction. Initiating Validation Master Plans for new projects. Developing manufacturing processes for new projects. Performing IQ, OQ, PQ protocol writing and validation activities. Studying existing processes to implement improvements on new products. Performing NPI prototyping and project phases. Managing specifications and activities of process/product validation. Managing projects through meetings, milestone tracking, and project planning. Communicating business issues or opportunities to management. Performing other duties as assigned. Requirements include a Bachelor's degree in Engineering, 3+ years of medical device NPI validation experience, proficiency with SolidWorks, knowledge of GMP, risk management, and familiarity with standards like ISO 13485 and FDA 21 CFR Part 820. Experience with ADAPTIV, Windchill PLM, and good communication skills in English are also required. This role is at an associate level, contract employment, within the pharmaceutical manufacturing industry, located in Irvine, CA, with salary ranges between $82,500 and $157,500.
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