We are seeking candidates with a strong engineering background and hands-on experience in regulated manufacturing environments, preferably within the medical device industry. Ideal candidates will have direct experience with process validation activities including characterization, OQ, and PQ (non-cleaning), as well as equipment qualification such as URS, FAT, IQ, OQ, PQ, and TMV (non-laboratory equipment). Experience developing and executing validation strategies, flowing design requirements into manufacturing controls, and supporting design transfer activities is essential. Candidates should also be familiar with risk management tools such as pFMEA, possess basic statistical skills (Minitab preferred), and have participated in project-based validation work that demonstrates practical application of these concepts.
Project: 6 new manufacturing lines for a medical devices company in Juncos-PR
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Founded on November 2010, CIS International is servicing companies within the Medical Device, Pharmaceutical, Biotechnology, Food and Beverage, Chemical, Manufacturing industry, and others.
As part of our process of adaptation to the changes that the market represents, our company has been studying the international market for approximately 3 years. With this, we seek to support new and existing customers outside Puerto Rico, such as the United States, India and Dominican Republic.
