A leading contract manufacturer for Medical Devices is in immediate need of a Sr. Automation Engineer for a 3-6 month project that will be based fully onsite in either Scottsdale or Phoenix.
Top Requirements:
BS degree minimum in Engineering.
Experience managing multiple capital equipment projects within FDA-regulated industry.
Subject Matter Expert (SME) of high-volume automated manufacturing equipment/systems.
Proficient in data analytics, Six Sigma, and lean manufacturing principles to drive projects (preferably proficient in Minitab).
Proficient in technical writing with experience developing and executing documents such as URS, engineering studies, validation protocols, work instructions, etc. (ideally has experience with ISPE GAMP 5 standards).
Responsibilities:
Champion new capital equipment projects (high-volume automated manufacturing cells/lines over $1M).
Develop User Requirements Spec (URS), Equipment Spec (ES), and consolidate all relevant information to acquire competitive bids from multiple machine builders.
Project management through equipment design and build, process development, validation, and commercialization.
Prepare RFP (request for proposal) and RFQ (request for quotation) documents for external contractors and/or suppliers.
Interact as a single point of contact with customer and ensure requirements and expectations are understood and met.
Prepare, review, and/or approve qualification and/or validation documentation (VMPs, specifications, protocols, reports, etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
Collaborate with cross-functional teams to propose/drive improvement opportunities for new production lines