Production Process Engineer

About the position

The Production Process Engineer provides direction and support to the manufacturing area utilizing industry standard problem-solving skills and acquired scientific/engineering knowledge to resolve manufacturing issues that impact product quality and delivery. Key activities include, but are not limited to, monitoring of current manufacturing processes, reduction of variation, control/mitigation of process drift, leading / supporting troubleshooting investigations, implementing manufacturing process improvements, assessing feasibility of new manufacturing technology, ensuring manufacturing process robustness, revising/creating new documentation for Manufacturing (manufacturing instructions, routings, bills of material, SOPs, etc.), validation of new or improved manufacturing processes and equipment and integrating new products from R&D into manufacturing. This role is located in Athens, Ohio.

Responsibilities

• Identifies and owns process improvement initiatives related to production throughput, product yield, labor efficiency, product quality and OEE performance.
• Characterizes, optimizes, validates and completes ECOs for manufacturing processes to improve value stream performance.
• Lead CAPA and NCMR investigation processes (RCFA, 5 Why, Cause & Effects, DOE, Cause Mapping) and supports Quality Engineers in the execution of defined corrective actions.
• Coordinates failure investigation and deviation requests with Production Science & Quality Engineering team members.
• Supports the internal auditing of manufacturing processes by working with a cross-functional team to document findings and explore corrective actions.
• Oversees new product & process development for operations during the transfer to manufacturing.
• Tests and verifies new product manufacturing specifications per R&D requirements.
• Develops manufacturing processes, QC methods and demonstrates process feasibility using prototype equipment for new product launches.
• Determines if manufacturing scaleup and quality requirements are obtainable during new product transfer from R&D.

Requirements

• Bachelor's degree in engineering, life sciences, biotechnology or operations or an equivalent combination of education and experience.
• Experience with Quality Management Systems
• Direct experience with production planning and scheduling process
• Proven track record of project management
• Strong analytical capability and communication skills
• Knowledge of techniques for effectively maximizing manufacturing, testing & distribution process of finished goods
• Ability to be successful in influencing leaders, peers, and cross functional team members to work together to define issues, develop plans and implement actions on projects
• Ability to identify and correct complex problems by reviewing related information to develop and evaluate options and implement solutions
• Proven leadership skills with proven ability to facilitate effective cross-functional business improvement
• This position is not currently eligible for visa sponsorship.

Nice-to-haves

• 3-5 years' experience in a manufacturing, production laboratory, or pharmaceutical industry environment
• Experience leading Kaizen events including elements such as standard work, cell design, process, and product 3P, Value-Analysis/Value Engineering, error-proofing, material flow, heijunka, and kanban in a manufacturing environment
• Familiarity with ISO and FDA standards
• Knowledge of ERP systems required, SAP preferred.
• Lean certification