Senior Sanitary Process Engineer at Agile… · Sheboygan

Company Description

Founded in 1976, Rockline is a family owned and privately held company who partners with recognized companies in the healthcare industry and professional markets. Rockline is one of the world’s leading developers, manufactures, and distributors of coffee filters and wet wipes sold throughout the world. Rockline is the largest supplier of coffee filters and private label personal wipes in North America. Rockline’s Contract Manufacturing Services provides development and manufacturing for some of the largest brands in the market as well as innovative start ups. Rockline continues to partner with companies in the healthcare institutional, and professional markets to drive health and safety. Some of the products manufactured and distributed by Rockline include OTC antibacterial wipes, disinfectant medical device wipes, household cleaning and disinfectant wipe products, adult incontinent wipes, and a variety of personal wipe products for people of all ages.

Job Description

· 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.

Qualifications

Bachelor Degree

Additional Information

All your information will be kept confidential according to EEO guidelines.