One of my major national client hiring firms seeks: : Automation Engineer Medical Equipment / Devices Raleigh/Durham area Base Salary - $80,000 - $95,000 Ideal Candidate has 5+ to 7 years of experience - direct - recent and exclusively from drug/ pharma / biotech products or other FDA regulated industry No Management Experience Required Will Travel Occasionally

Provides automation/electrical controls engineering skills and activities during design, installation, validation, and operation of new sterile manufacturing plant and processes. Works closely with manufacturing and process engineers to design and implement low cost, highly efficient manufacturing process. Experience required in management activities surrounding capital projects or internal upgrades. Key process experience required in syringe filling, sterilization, high purity utilities controls, and packaging. Supports and specifies MES systems, building management systems (BMS), PLC's, IT interfaces, and automation control systems.

Provide input to systems design, construction, start-up, and commissioning of engineered process equipment. Thereafter works to ensure continuous improvement and operation in accordance with relevant federal (FDA/DEA) regulations under 21CFR Part 11 for control systems. . Interact with all required support activities (quality, production, facilities, purchasing, validation, etc.) to bring automation projects to fruition.

Responsible for leading project teams. Leads compliance of control system design to meet all cGMP requirements. Strategic Impact/Accountability - This position directly impacts the cost position of manufactured product, and fiscal impact based on actual vs. promised delivery dates.

Accountable for performing appropriate level of engineering and technical related activities around process improvements and new product developments.

Sphere of Influence (liaison) - Other plant engineering staff, R&D engineering outside of plant, machine vendors, platform functions, in-house technicians and operators. May be called upon to reverse tech transfer key automation enhancements to small scale R&D facility.

Required BSEE or Controls Engineering or related. AutoCAD, Microsoft Office, Technical Writing, Presentation Skills, Project Management Skills, Risk Management Skills, Knowledge of Materials Processing, Knowledge of Machine Shop Practices, Knowledge of Materials, Knowledge of Safety and Ergonomics, Knowledge of Cost Estimating. Advanced experience with robotics and process flow required

Technical Area of Expertise - General control system electrical Engineering expertise related to automated assembly, sterile processing, critical utilities, BMS, MES, packaging equipment for high volume production.

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