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Equipment Validation Engineer

Company: Cepheid
Location: sunnyvale
Posted on: May 3, 2021

Job Description:

POSITION SUMMARY:The Equipment Validation Engineer is responsible for defining and executing validation strategy and coordinating validation activities required to launch new equipment into the production environment. The successful candidate will perform validation activities that include Equipment/Utility/Facility Qualification, Cleaning Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire. Work with a cross functional team to support manufacturing capacity expansion projects.ESSENTIAL JOB RESPONSIBILITIES:Design and perform process characterization studies and experiments using statistical methods to develop new and/or improve existing assembly processes.Validate new automation processes, equipment and/or designs in collaboration with a diverse functional engineering team.Generate and sustain Verification/Validation protocols (I/OQ, PQ) and related technical documents to support the transfer of processes into Production.Provide technical assessment and validation review/approval for engineering, process and standard operating procedure changes.Assist in failure investigations and root cause analyses as they relate to process performance.TRAINING RESPONSIBILITIES: Complete all assigned and required training satisfactorily and on timeMINIMUM REQUIREMENTS:Education and Experience (in years): Bachelor's degree in field with 5+ years of related work experience OR Master's degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience. Knowledge and skills: Strong working knowledge of GMP, ISO, and FDA rules and regulatory requirements.Strong data analysis skills utilizing software such as MiniTAB and JMP.Proven experience with DOE's, root cause analysis, process engineering, failure investigations and automated assembly equipment.Experience developing and executing IQ, OQ and PQ documentation for GMP equipment.Excellent verbal and written communication skills.Familiar with statistical process control methods.Physical requirements/abilities: Ability to work in clean room environment.Ability to use hand or power tools.Ability to stoop, kneel, crawl, lift, pushPREFERRED REQUIREMENTS:BS in Mechanical, Biomedical Devices, Plastics Engineering (or a related field).MS degree in Mechanical, Biomedical Devices, Plastics Engineering (or a related field).A minimum of3+ years engineering experience in medical device or other regulated industry.Prior experience in biomedical device assembly process development.Quality ManagementSystemexperience.The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.

Keywords: Cepheid, Sunnyvale , Equipment Validation Engineer, Other , sunnyvale, California

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