Senior Software Quality Engineer-3733120830
Johnson & Johnson Vision Care, a member of Johnson & Johnson''s Family of Companies, is recruiting for a Sr. Software Quality Engineer, to be located in Jacksonville, Florida.
Johnson & Johnson Vision Care, Inc., - VistakonŽ Division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUEŽ Brand contact lenses. Ever since ACUVUEŽ transformed vision correction in 1988 with the world''s first soft disposable contact lenses, we''ve passionately pursued new technologies and the highest quality standards. We''re proud that ACUVUEŽ lenses are worn by more people than any other brand.
This position will be responsible for developing, enhancing, and implementing software validation programs/policies and procedures for manufacturing equipment/process and computerized (automated) systems, including training programs. This role will lead validation activities/projects as well as create, review and/or approves software, equipment, facilities, formulations, and product/process validation documentation, including site validation master plan. This position will also implement programs/policies/procedures with respect to Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management. Proactively examines systems, processes, and standards to identify areas for review, change, or elimination. Establishes linkages to other quality systems/programs like Technology Transfer, Change Management, Test Method Transfer, and CAPA. Provides consulting, training and guidance on validation principles, risk management, root cause analysis, statistics, and quality systems. Perform other related duties as assigned by management.
This position ensures quality and validation programs are well-defined, executable, meet customer and business needs, and are in compliance with regulatory requirements. Implements global programs/policies/procedures with respect to Software Validation, Revalidation, and Commissioning & Qualification of Hardware Systems, Root Cause Analysis/Failure Investigations, and Risk Management. Has thorough understanding of System Development Life Cycles for FDA regulated applications. Develops Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports. Has thorough knowledge of US CFR 21 Part 11 regulations and/or knowledge of US CFR 200 or 300 or 800 series. A Senior SQE is experienced with high volume application testing environments, with automated Software Testing tools, and with a Corrective and Preventative Action program. They have an understanding of Sarbanes-Oxley (SOX) regulations, and are able to work within, and/or lead a Project Team. Manages validation projects in support of existing products/processes and propagations of new products at the Jacksonville campus. Besides software/hardware validations, this position may also oversee qualification activities related to repackaging and manufacturing projects.
This role will have validation responsibilities include, but not limited to the following: prioritizing and planning all assigned projects for the QA validation department. Leading validation project planning, facilitating risk analysis, perform/review failure investigations documenting & executing qualification protocols and reports. Facilitating change validation supporting testing labs, formulations, and facilities qualifications. Developing validation training modules. Implementing new or changed quality systems (programs/policies/procedures). Conducting validation and statistics training for Operations, QA, IT, and MSE personnel. This position will adheres to environmental and safety policies and procedures and supports department''s safety and environmental objectives.
This position requires a minimum of a bachelor''s degree. Candidates with a degree in chemistry, mathematics, engineering or computer science are preferred. Candidates that possess a master''s degree or possess advanced course work in technical systems or continued education in technical disciplines are preferred. This position requires a minimum of 6 years work experience in Software Validation/Statistics/Process Engineering or Test Methods. Candidates with pharmaceutical or medical device experience are preferred. Candidates with a CQE certification are also preferred. This position requires an excellent understanding and application of one of the following principles, concepts and practices of Risk Management, Statistical Methods, Validation, Commissioning & Qualification, Root Cause Analysis/Failure Investigation, and the QSR/ISO Regulations. This position requires an excellent communication, interpersonal, conflict management, and organization skills. In addition, this position requires strong leadership and coaching skills. This position will require 10% travel and will be based in Jacksonville, FL.
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Primary Location:North America-United States-Florida-Jacksonville
Organization:Johnson & Johnson Vision Care, Inc. (6094)
Job Function:Quality (Eng)