Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Johnson & Johnson Vision is recruiting for a Principal Software Quality Engineer to be based in Jacksonville, FL.
The Principal Software Quality Engineer would be responsible for the Franchise administration of quality systems such as Global Application Change Control (GACC), ensuring the change request program is well-defined, executable, meeting customer and business needs, and in compliance with regulatory, sector, and franchise requirements.
• Responsible for analyzing and monitoring efficiency and effectiveness of metrics associated with Change Control.
• Actively examines change control systems, processes and standards to identify areas for review, change or elimination. Establishes linkages to other key quality systems/programs such as Design Controls and Risk Management. Provides leadership in related technical reviews of change requests providing mentorship in the area of compliance to current regulations and standards governing change control.
• Functions as an authority in Computer Systems Validation (CSV) principles. Works closely with R&D, Operations, and Regional Partners in building and delivering innovative and compliant software validation approaches for day-to-day support and emerging business needs. As a primary responsibility, directs all aspects of the software quality sub system ensuring that all requirements under the organization are met.
• The Principal Software Quality Engineer partners with project teams to implement qualification strategy utilizing Good Engineering Practice (GEP). Ensures quality and validation programs are well-defined, executable, meets customer and business needs, and are in compliance with regulatory requirements.
• Performs a variety of Computerized System Validation (CSV) assignments at an advanced technical expertise level utilizing a wide range of Industry CSV techniques and principles: project leadership, computerized system requirement and development of CSV programs and associated training.
• Prepares, reviews and approves project documentation including site validation master plan, monitors and evaluates changes to validated computerized systems. Develops procedures associated with engineering qualification of equipment and software. In addition to software and hardware validations, this position may also handle qualification activities related to repackaging and manufacturing projects.
• Has complete understanding of System Development Life Cycles for FDA regulated applications. Develops Computer System Validation work for FDA-regulated applications: Validation Plans, Requirement Specifications, different levels of software testing scripts (IQ, OQ, PQ), HMI, PLCs Traceability Matrix, and Validation Reports. Has thorough knowledge of US CFR 21 Part 11, part 820 regulations and/or ISO13485
• Leads, manages, review and evaluate status of multiple company projects within the CSV area of responsibility. Leads on validation protocols, test plans and reports. Reviews and approves project documentation; monitors and evaluates changes to validated computerized systems.
• Implements global programs/policies/procedures with respect to Software Validation, Revalidation, Commissioning & Qualification of Hardware Systems, Root Cause Analysis/Failure Investigations, and Risk Management.
• Adheres to environmental policy and procedures and supports department environmental objectives.
• Franchise Administration of Global Application Change Control (GACC). Manages, plans, conducts, leads, multiple CSV projects of significant magnitude across various disciplines involving the use of Computerized Systems with considerable latitude for action or decision. Utilizes a wide range of engineering principles and works with advanced technical expertise, to lead validation activities.
• Supports Technical Review Board discussions and follows up on identified actions. Provides leadership, mentorship and training of CSV and validation programs, principles, risk management, root cause analysis, statistics, quality systems and Good Engineering Practice (GEP) policies and procedures for facility, utilities, manufacturing process equipment and associated computerized (automated) systems and software
• Develops, improves, and implements software validation programs/policies and procedures for manufacturing equipment/process, programs/policies/procedures with respect to Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management.
• Actively monitors and examines systems, processes, and standards to identify areas for review, improvement, change, or elimination. Establishes linkages to other quality systems/programs like Technology Transfer, Test Method Transfer, and CAPA.
• Reviews and approves internal and vendor equipment and software development and test documentation.
• Performs other related duties as assigned by management.
- Bachelor’s Degree - Engineering/Computer Science
- Master’s Degree - Engineering/Computer Science
or Professional Association preferred
- A minimum of 10 years’ regulated industry
experience with BS degree.
- A minimum of 7+ years with MS degree.
- Membership in IEEE, ISPE and ASQ preferred.
- Working experience in Computerized System
- Excellent communication, social, organizational
and analytical skills.
- Thorough knowledge, understanding and application
of principles, concepts and practices of GEP, GAMP and GMP/ISO regulations.
- Excellent mentoring, coaching skills.
- Demonstrated leadership abilities.
Johnson & Johnson is an Affirmative Action and Equal
Opportunity Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual orientation,
gender identity, age, national origin, or protected veteran status and will not
be discriminated against on the basis of disability.
Johnson & Johnson Vision Care, Inc. (6094)Job Function
Quality SystemsRequisition ID