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Process Engineer
3 months ago
About the Company:TECHNICAL OPERATIONS ENGINEER (PROCESS)
About the Role:• 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.
- Responsibilities:Evaluate processes at contract manufacturers with the aim of continuous improvement via improved efficiencies, equipment improvements, 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 improvements.
- 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 2
- 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.
Qualifications:• 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 or Process 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.