Full Job Description:
Scope of Position:
In this role, you will lead process development initiatives to improve existing products and manufacturing processes and introduce new manufacturing and engineering processes to the Treyburn site. We look for you to develop and integrate new technologies to the manufacturing environment and support the daily response to operational upsets and champion long-term solutions and systems improvements to enhance the safety, quality, productivity, and reliability of manufacturing systems. You will be responsible to handle capital and non-capital projects from concept through implementation including determining project scope and resource needs, establishing mold and equipment specifications, completing FATs and DOEs, and writing and executing validation protocols. Additionally, you will actively support, improve, and ensure compliance to the site business and quality management systems through documentation preparation, process auditing, and completion of corrective actions in response to customer complaints and audit findings.
This position works closely with operations management, functional leaders, engineers, and external partners to establish work priorities and work assignments across the various functional groups.
Day to Day Responsibilities:
• Manufacturing Support: Actively collaborate with other site engineers, operations personnel, and suppliers to maintain and improve operations.
• Work with Operations to gather support need information and provide updates on process status.
• Quickly respond to production and process upsets, solve production issues, diagnose problems, and implement corrective action (machine fix, process change, etc.) to reestablish operations.
• Work with operations to further develop SPC/SQC for process discipline and control (PD/PC).
Technical Leadership:
• Provide technical leadership in assigned processes.
• Act to continuously improve and expand the site’s core process capabilities.
• Act to continuously improve overall plant performance through project identification and completion.
• Use of engineering first principles like MEE to drive mechanistic understanding and root cause identifications
• Lead standardization efforts in assigned processes.
• Look for standardized approaches for machine designs or work processes to maximize plant standardization, operational efficiency, and future project efficiencies.
• Ensure alignment by all site functional groups to standard processes, business and quality systems, and governmental regulations (OSHA, ISO, QSR, FDA, GMP, etc.).
• Identify and implement modifications to production equipment and processes to improve overall equipment efficiency (OEE) by improving process yield, improving production rate, and improving machine availability.
• Documents changes via the change control process.
• Train maintenance and operations personnel on processes and machinery to transfer operations knowledge and ensure operational efficiency and product quality.
Process Development:
• Gain process expertise through training and experimentation then apply process expertise to develop robust manufacturing systems.
• Develop robust processes & architectures via use of tools such as PQA & Six sigma.
• Use Six Sigma tools for, process capability studies, statistical process control determination, measurement systems analysis, and development of process controls systems.
• Act to continually improve operations processes through projects, experimentation, designs, and process enhancements.
• Plan, specify, and implement process improvements, machine modifications and tooling improvements.
Process Validation and Quality Systems Responsibilities:
• Validate production processes as needed using site validation processes.
• Establish and implement validation master plans and document validation results. Identify processes operating outside of validated state through production audits and take corrective actions to return processes to normal operation.
• Rigorously adhere to requirements of the plant quality systems including compliance to the change control procedure when introducing or modifying manufacturing processes and equipment.
• Ensure compliance of business and quality systems in manufacturing, i.e. OSHA, ISO9001, ISO13485, QSR CFR 21 part 820, GMP, etc. through audits against documented procedures.
• Take corrective action when audits identify any non-conforming process. Travel Requirements: Limited project or training related.
Travel Requirements:
• Up to 25%; majority domestic
Hours of work/work schedule/flex-time:
• This position supports a 24/7 manufacturing operation.
• Respond to off-hours calls to resolve manufacturing process upsets or plant systems downtime events.
• Occasionally flex working schedule as required to meet business needs.