Principal Engineer
Thousand Oaks, CA
Req ID 51448BR
Business Title
Principal Engineer
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Thousand Oaks, CA
Shift_
1st
Job Description
Summary
Incumbent is responsible for managing the development and execution of Biotechnology computer system validation projects using life cycle methodology and project management techniques.
Essential Duties & Responsibilities
•Incumbent will assist in computerized system validation projects that will address new facility construction, new equipment installation, and revalidation of existing control and laboratory systems. •Incumbent will assist in facility/system/process improvements, modifications and deviation investigations. •Incumbent will organize and archive validation documentation. •Interpret and appy regulatory requirements, including 21 CFR Part11, industry guidelines like GAMP, and presentation of validation packages during regulatory audits. •Create and execute IQ,OQ and PQ validations as required. •Incumbent will schedule, plan and manage installation, operation and performance qualifications of complex manufacturing computerized systems that control equipment, utilities and facilities. •Support regulatory submissions. •Present as a subject matter expert during regulatory inspections to demonstrate compliance of the qualification and quality programs.
Job Requirements
Qualifications
•Current understanding of pharmaceutical industry regulations and trends in the regulatory environment. •Strong interpersonal communications skills with excellent technical writing abilities •Demonstrated application of engineering principles on projects. •Possess in-depth knowledge of GMP and regulations related to Computer System Validation. •Proficient in Microsoft Office tools (Power point, MS Project, Excel, Word) •Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction. •Must have passion to innovate and drive for solutions. •Must display personal accountability for results and integrity. •Must display eagerness to learn and continuously improve. •Must have uncompromising dedication to quality. •Must have relentless focus on rapid and disciplined action. •Must have respect for individuals and the diverse contributions of all. •Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction. •Must have passion to innovate and drive for solutions. •Must display personal accountability for results and integrity. •Must display eagerness to learn and continuously improve. •Must have uncompromising dedication to quality. •Must have relentless focus on rapid and disciplined action. •Must have respect for individuals and the diverse contributions of all. Education and/or Experience
•Bachelor's degree in engineering or scientific discipline. •Minimum of 5 years of experience in technical Quality, Validation or related field in Pharmaceutical, Biotechnology or Medical Device manufacturing. •Validation experience related to Computer System Validation for Automation Systems, Emerson Delta V, OSI PI and RtReports, SCADA/PLC. Working Environment
•Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments. •May be around moving equipment and machinery. •Must be able to work more than 8 hours a day or 40 hours a workweek as required. •Inside working conditions. •May be required to travel for business reasons, e.g. training and meetings. •Will have interaction with other people. •Pace may be fast and job completion demands may be high. Physical Demand
•The overall physical exertion of this position is Light work. •May be required to use hand / finger feel for computer use. •May be required to move or lift testing equipment up to 20 pounds. •May be required to balance occasionally when completing the following job duty (Gowning).
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.
