Process Engineer

We have an immediate opening for a Process Engineer in the Inhalation Drug Delivery manufacturing team at Kindeva’s Northridge, CA manufacturing facility. Application of technical knowledge and extensive experience will be required in to lead process improvement projects, develop, and install capital equipment, and improve product quality. Focus will be on high-speed automated formulation, filling, and packaging equipment.
 

Job Responsibilities

• Develops into subject matter expert in the Inhalation Manufacturing area for high-speed automated formulation, filling, and packaging equipment.
• Initiates, identifies, recommends, and oversees programs in the manufacturing area of responsibility to improve safety, quality, service, cost, and engagement.
• Leads equipment-based breakdown resolution and quality investigations, proactively drives innovative solutions.
• Partners with plant engineering to prioritize corrective maintenance to minimize downtime and optimizes preventative maintenance procedures to minimize equipment breakdowns.
• Responsible for leading projects, including the planning, installation, and qualification of new equipment.
• Supports New Product Introduction (NPI) related activities, responsible for leading equipment related NPI activities to meet customer and/or product needs.
• Authors and/or revises technical documents (i.e. SOP, validation protocols, investigations, technical reports, etc.)
• Develops extensive lean six sigma (LSS) knowledge and techniques and runs projects to improve manufacturing processes for the product lifecycle.
• Identifies and implements a comprehensive education plan to continually advance technical skills and personal development as well as enhancing organizational effectiveness. Establishes self as a resource within immediate work group.
• May be assigned product engineering tasks such as customer communications.

Required Skills & Experience

• Bachelor's degree in Mechanical, Biomedical, Systems/Electrical, Chemical or Manufacturing Engineering from an accredited University
• At least 5 years of experience in process or project engineering within the manufacturing industry.

Preferred Qualifications

• Prior experience in Medical Device/Pharmaceutical industry (cGMP)
• Prior experience in the installation and qualification of automated manufacturing lines.
• Solid background in process automation.
• Prior experience in New Product Introduction activities
• Prior experience with high-speed packaging or formulation/filling and/or packaging operations.
• Prior experience in CAPA closure and/or Quality Investigation Report activities.
• Experience with leading DMAIC Six Sigma projects – Green Belt Certified.
• Experience with developing and implementing Lean Systems and Standard Work.
• Solid analytical and statistical skills.
• Solid interpersonal and communication skills, both written & oral.
• Cross functional team contributions and leadership skills