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Equipment Engineer

3 months ago

Warren, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities: Operational Activities. Executes equipment calibration, preventative maintenance, performance verification and repair activities in laboratory and manufacturing areas. Supervises vendors for calibration, preventative maintenance, performance verification and repair functions. Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness. Ensures all calibration, PM, and performance verification records are filed appropriately after approval. Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, and Cryopods). Supports multiple sites within Warren and Summit. Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions. uthors and supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment. Support the development, review and approval of calibration and maintenance plans in site CMMS system. Supports the execution of process improvement studies, as required. dheres to written policies and procedures governing the Laboratory Systems Management department activities and the equipment they manage to ensure compliance with approved standards. Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment. Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available. Inventory Management. Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed. pproves Change Request, Asset Inductions, and Work Request. pproving Calibration and Maintenance forms. Perform Client's investigations. Review and approve calibration and maintenance work. Regulatory Responsibilities. Maintains all required Corporate, Facilities and EHS training as required. dheres to all safety procedures and hazard communication. May be called upon to act as SME in both internal and regulatory audits. Requirements: Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. BS in Engineering or Science related discipline required. Minimum 3 years of experience in FDA-regulated industry. Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.) Maintenance coordination / planning experience preferred. Experience working in a clinical environment preferred. Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs. bility to sit, stand, walk, and move within workspace for extended periods. bility to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling.