Engineering Solutions Consultant
hace 2 semanas
About This Role:
This role is responsible for providing comprehensive technical support for the FDA-regulated industry, including evaluating utility systems, process maintenance, instrumentation, and electrical systems to ensure compliance with industry standards and regulations. The ideal candidate will have a strong background in engineering, quality assurance, and technical support, with excellent communication and problem-solving skills.
Key Responsibilities:
- Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
- Participate in the coordination of TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
- Assist during FDA and other regulatory agency inspections.
- Provide TECHSUPPORT in response to the FDA and other regulatory agencies.
Qualifications:
Bachelor's degree or Associate's degree and 4 years of directly related experience or High school diploma / GED and 6 years of directly related experience. Key qualifications include leadership, verbal communication, written communication/technical writing, organization, facilitation, and analytical problem solving.
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