Job description
We have an immediate opening for a Process Engineer in the Transdermal Drug Delivery manufacturing team at Kindeva’s Northridge, CA manufacturing facility. Application of technical knowledge and extensive experience will be required to lead process improvement projects, develop and install capital equipment, support the launch of new products, support the launch of new products and improve product quality. Focus will be on high-speed automated packaging, coating, and converting equipment.
Job Responsibilities
- Develops into subject matter expert in the Transdermal Manufacturing area for high-speed automated packaging, coating, and converting equipment.
- Initiates, identifies, recommends, and oversees programs in the manufacturing area of responsibility to improve safety, cost, service, and quality.
- Leads equipment-based breakdown 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, validation, and installation of new equipment.
- Supports New Product Introduction (NPI) related activities, responsible for leading equipment related NPI activities to meet customer and/or product needs.
- Actively participates in lean, safety, and compliance activities.
- Authors and/or revises technical documents (i.e. SOP, validation protocols, investigations, technical reports, etc.)
- Has 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.
- Bachelor's degree in Mechanical, Systems/Electrical, Chemical or Manufacturing Engineering from an accredited University
- At least 3 years of experience in process or project engineering within the manufacturing industry.
- Prior experience in Medical Device/Pharmaceutical industry
- Prior experience in New Product Introduction activities
- 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