Operations Engineers (Fortune 100 #1 Supplier!)
***Pertinent (GMP environment), internship level experience is OK.
***Validation, programming, and start-up/qualification experience is preferred.
The person hired for the position of Operations Engineer will be a key member of the inhalation drug delivery manufacturing team at the Northridge, CA Manufacturing Facility. Application of technical knowledge and experience will be required to lead projects and investigations, solve complex problems, and ensure compliance with established standards.
Primary Responsibilities include but are not limited to the following:
- Develops into subject matter expert in the inhalation manufacturing area.
- Identifies, recommends, initiates, and implements programs in manufacturing area of responsibility to improve and/or enhance: 1) product cost, service, and quality, and 2) process safety and health/environmental impact.
- Leads equipment-based breakdown and quality investigations, proactively drives innovative solutions. Partners with maintenance to prioritize corrective maintenance to minimize downtime and optimizes PMs to minimize equipment breakdowns.
- Responsible for leading large, complex projects, including the planning and installation of new equipment in the inhalation manufacturing area (formulation, filling, packaging).
- 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 (ie. SOP, Protocols, Investigations, PD Tech Reports, etc.)
SKILLS AND QUALIFICATIONS
- Possess a Bachelors degree or higher in engineering or technical discipline from an accredited institution
- Minimum 1 year of technical experience in an engineering role, preferably in manufacturing
- Prior manufacturing experience in a GMP environment
- Previous experience with root cause analysis and project management
- Lean Six Sigma Green Belt Trained
- Strong written and verbal communication skills and ability to work in a team environment.
“The successful candidate will be required to verify identity and eligibility to work in the United States”