Validations Engineer

Company: Abbott
Location: Santa Rosa
Posted on: December 4, 2019

Job Description:

Validations Engineer REQ******** NA-USA-California-Santa Rosa Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Validations Documentation Specialist is within our Toxicology Laboratories located at Santa Rosa, CA. Primary designing, executing, and documenting validation plans and protocols for the determination of drugs and metabolites in biological matrices. This role will instrumental in providing accurate and timely test results to our clients. This job description will be reviewed periodically and is subject to change by management. RESPONSIBILITIES: Author and revise validation plans, protocols, and SOP's Oversee protocol execution while coordinating with Method Development, Validation, Production, QA and QC personnel Summarize and evaluate protocol data, including resolution of discrepancies and exceptions Work with Production department to assist in maintaining quality in production. Review or re-qualify equipment, instruments, and facilities to maintain their validated state as defined by SOPs. Present project results and recommendations to department management Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise Maintain and meet the highest standards in quality and regulatory compliance. Follow, understand and comply with SOP's and policies on cGLP's and safety. Perform any other duties as designated by the Manager, Technical and Instrumentation or dictated by the needs of the laboratory BASIC QUALIFICATIONS/EDUCATION: Bachelor's degree from an accredited college or university in engineering or physical or life science and 4 years of experience in a GMP environment.PREFERRED QUALIFICATIONS: 8 + years of experience in pharmaceutical validation or equivalent industry experience. Subject matter expert for the following areas: validation of software, automation, analytical instruments, or general equipment validation. Experience with change management assessments for validated equipment, systems, and processes. Experience with total method validations (TMVs) for LC-MS-MS instrumentation.COMPETENCIES:Achieving results About AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries. Connect with us at **************, on LinkedIn at ********************************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to *********************. #LI-NW1 Engineering Research and Development Full-time

Keywords: Abbott, Santa Rosa , Validations Engineer, Engineering , Santa Rosa, California