Technical Operations Engineer
This position is responsible for providing Process Engineering and Packaging support to the Technical Operations Department. This role spans across all Shaklee products, including nutraceuticals, household products, food items, and personal care products. The position is responsible for ensuring that contract manufacturers have established adequate programs, equipment, procedures, and processes for manufacturing and packaging Shaklee products to ensure finished product meets Shaklee and regulatory requirements and expectations. This person will act as the primary technical interface between Shaklee QA, R&D, Operations and the contract manufacturers to ensure that all documentation, including formulas, specifications, processes, and methodologies are provided, understood, and implemented. This position will be required to visit the contract manufacturer facilities in support of product/process qualifications, product transfers, process/product/efficiency optimization projects, as well as, in response to escalated product complaints and product maintenance issues. While on-site at contract manufacturers, this role will be responsible for understanding the upstream and downstream processing operations via diagnosing process issues and process and/or critical control points, then working with the contract manufacturer on process improvements and implementation. In addition, this position is the owner of packaging via recommending, evaluating, qualifying, and approving new components, troubleshooting, and providing technical expertise for component issues, and staying current on new packaging technology.
Within the Distribution Center, the position will coordinate the testing of new package structures and configurations as requested by internal and external customers. Additionally, this position will provide technical support for all internal packaging-manufacturing equipment and/or processes that may also be implemented within Shaklee. The position will work with Distribution Center Operations and Logistics on internal processing solutions and improvements; as well as provide technical expertise for internal processes and any additional duties as assigned.
ESSENTIAL FUNCTIONS:
· Evaluate Contract manufacturing capabilities for product scale up from bench top to product launch, to meet Shaklee expectations and regulatory requirements.
· Perform product maintenance functions regarding troubleshooting, researching, root cause analysis and correcting product issues. Provide onsite process and technical support for new and ongoing manufacturing and packaging operations, addressing specific product concerns regarding process variation, and test methodology.
· Evaluate processes at contract manufacturers with the aim of continuous improvement via improved efficiencies, equipment improvments, and/or modifications to control processes.
· Perform statistical analysis on reported QC test data, analytical and physical, of contracted manufactured bulk products to provide supporting data and documentation for recommendations for product and/or process parameters changes, and/or sampling, controls, or process improvments.
· Perform finished goods inspections and investigations to verify contract manufacturer capabilities meet Shaklee product requirements.
· Author final technical reports and summaries from contract manufacturer visitations detailing operational activities and production data
· Conduct packaging evaluations on current and new components to support implementation, ensuring contract manufacturer capabilities are compatible with componentry.
· Recommend, evaluate, qualify, and approve new components.
· Troubleshoot and provide technical expertise for component issues and stay current on new packaging technology.
· Provide technical support for all internal packaging-manufacturing equipment and/or processes that may also be implemented within Shaklee.
· Other related functions/duties as assigned.
· A minimum of three years related experience in the FD&C industries, with at least two years of combined experience in production, manufacturing, or processing
· A Bachelor’s Degree from an accredited institution in Chemical Engineering or related field.
· Experience of being directly involved with specifications, standard operating procedures, root cause analysis and problem solving.
· Exhibit high energy level, astute sense of urgency and very open interpersonal skills to work in cooperation with the Operations, QA and R&D teams and as well with third-party manufacturers.
· An understanding of quality technology at a level normally acquired through completion of a CQE and ASQ certification program desired.
· Expertise in lean manufacturing and six sigma.
· A comprehensive knowledge of cGMP requirements for FD&C products.
· A practical understanding of statistical methodology and sampling.
Willingness and ability to travel to suppliers and contract manufacturers as needed and required