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Equipment Engineer
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- The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers.
- The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Working knowledge of scheduling software and systems, and inventory management systems, Blue Mountain RAM and Maximo preferred.
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