Position Description:

We are currently seeking a Senior Staff Engineer for our Irvine, CA. manufacturing facility.

JOB PURPOSE:
Provide Engineering support and project management skills toward product design, development, and testing. Provide technical experience in process development.

ESSENTIAL FUNCTIONS:
Research, develop and prepare specifications for improvements in existing and/or new products,, processes, equipment and technology.

Support projects by contributing to the development of project schedules, teams, tracking costs, preparing status reports, conducting team meetings and communicating issues and progress to management.

Prepare RCIs including project description, schedule and costs.

Knowledge of applied statistics and DOE is a must

Supervise and direct contract personnel and outside vendors in the performance of contracted services.

Supervise daily activities of all levels of Engineering Aides.

Provide direction and technical decision making for management involving capital asset purchases and expenses for projects and/or strategic activities involving up to $5MM (capital/expense/revenue potentials).

Prepare and present technical investigative reports to middle level management.

Moderate degree of both internal and external personnel interfaces.

Preparation of specifications and protocols for the development, testing and qualification of equipment, processes and products.

Communicate, both verbally and written, project activities to supervisor.

QUALIFICATIONS GUIDELINES:
Required:
Bachelor’s degree in Engineering with at least 6-7 years experience in an Engineering position.

Desired:
A BS degree in Engineering with at least 5 years experience in a Pharmaceutical Engineering position.

Knowledge:
Demonstrated knowledge within an engineering specialty(s) area including product development, R&D and process development.

Understanding of basic statistics and its application in Engineering.

GMP knowledge applicable to the individual’s specialty(s) area.

Software packages such as project management, spreadsheets, word processors and packages unique to the individuals specialty(s) area.

Understanding of manufacturing methods related to the individuals specialty(s) area.

Skills/Abilities:
Use of computer and peripherals related to the specialty area.

Communication skills, both verbal and written, commensurable with dealings at the middle management level.

Preparation of RCIs with direction from supervisor.

Ability to work with vendors to develop work schedules and tasks within the individual’s specialty(s) area.

Demonstrated project management skills to run projects within the individual’s specialty(s) area.

Ability to work independently and within a team environment.

Ability to analyze, investigate and propose approaches to technical issues within the individuals specialty(s) area.

Demonstrated troubleshooting skills related to the individuals specialty(s) area.

Use of specialized equipment utilized in the troubleshooting, development, testing and qualification of equipment, processes and products.

Ability to write specifications and protocols for the development, testing and qualification of equipment, processes and products.

Special Requirements:
Domestic travel with the possibility of occasional international travel.