Senior Sanitary Process Engineer

· Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Chemistry, or other relevant scientific field.

· Eight to ten years of direct experience in manufacturing, engineering, quality assurance/engineering, or process cleaning is required. Of those eight to ten years, five must be related to chemical processing and three as a subject matter expert in process cleaning within a GMP industry. Because of the nature of our manufacturing process, your process cleaning experience should come in cosmetics, pharmaceuticals, medical devices, chemical processing, or food production.

· Previous experience interpreting and applying regulatory standards and risk analysis techniques

· Previous experience leading cross functional teams

· Training in and experience performing internal process audits of GMP production areas desired

· Ability to develop training materials and effectively train technical and operational staff.

The key functions of this role include:

· Establish and communicate common standards for effective cleaning and sanitization of chemical batching processes, fluid delivery processes, and product/material contact surfaces in accordance with applicable GMP standards for all production sites.

· Evaluate and develop cleaning and sanitization programs with manufacturing sites to assure compliance with GMP and Rockline standards. Develop common methodologies for the validation of cleaning processes.

· Participate with other engineering functions in the development of best practices as it relates to fluid system design, sanitary design standards, and sanitation practices.

· Review manufacturing site environmental monitoring programs and propose relevant improvements to reduce microbiological risk.

· Work collaboratively with plant leaders regarding investigations, and corrective actions relating to cleaning and sanitization of processing equipment, fluid delivery processes, and product/material contact surfaces.

· Develop monitoring and verification programs to continuously improve the overall quality and effectiveness of cleaning and sanitization programs at all manufacturing sites.

· Perform or coordinate risk based focused plant audits to identify and correct gaps in hygienic controls, which include sanitation protocols/procedures.

· Serve as liaison between Rockline and cleaning/sanitization industry trade group leaders to stay current with respect to technical developments in the areas of process cleaning and sanitization.

Bachelor Degree

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