Principal Engineer
Los Angeles, CA
Req ID 50079BR
Business Title
Principal Engineer
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Los Angeles, CA
Shift_
1st
Job Description
This position will have responsibility for applying a solid understanding of theories and practices such as risk-based validation approach toward the development of new or enhanced processes that improve or simplify validation of process control systems at the Los Angeles Manufacturing Facility and Van Nuys warehouse. This position also plans, executes and functionally directs important engineering assignments which require instances of independent judgment. Based on sound technical expertise, this position will participate as a key player with Engineering, Manufacturing and Quality Assurance/Quality Control, in computer process control system validation, project planning, and execution.
Duties include active participation in system and process specification, design review, validation planning, process implementation, and configuration management activities. You will be expected to seek input outside of business unit or division on programs of some magnitude, and expected to exhibit creativity and innovation in completing divisional and cross-functional/business unit responsibilities.
Essential Duties and Responsibilities
•Applies state of the art validation techniques to develop new and improved process control system validation processes.
•May lead large scale programs or several small projects with complex features and technological challenges.
•Independently plans, schedules and leads cross-functional team in detail phases of validation of process control systems.
•Provides technical direction.
•Reviews and analyze proposals and change requests to determine if benefits derived and possible applications justify expenditures.
•Responsible for preparation of computer process control system validation project schedule and cost estimates.
•May assist in analysis to justify project approval.
•Monitors all project expenditures and cost tracking.
•May supervise one or more engineers or contractors.
Job Requirements
Qualifications
•Must have hands-on experience in validation of DeltaV and computer-based process control system.
•Must be well versed in validation disciplines (e.g. process and equipment validation methods and procedures) and have working knowledge of chemistry and microbiology.
•Must also possess working knowledge of regulatory requirements and new developments for computer systems validation.
•Must be self-motivated, have good interpersonal skills,capable of analyzing and solving complex problems through innovative thought and experience.
•Knowledge of FDA Regulations (including 21 CFR Part 11), Good Manufacturing Practices (cGMP) and GAMP 5 guidelines.
•Ability to design and influence outside of immediate scope of responsibility. Successful track record of managing wide-ranging activities within the business unit. Education and/or experience
•BS in related engineering discipline or other scientific based discipline with advanced technical degree or equivalent experience.
•9-12 years of relevant technical experience.
•M.S. in Engineering and 5-7 years of experience or
•Ph.D. in Engineering and 3-5 years experience.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
