Senior Software Quality Engineer

Johnson & Johnson • Jacksonville, FL

6d • Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Jacksonville, Florida, United States of America Job Description: Johnson & Johnson, Vision Jacksonville, FL is recruiting for a Senior Software Validation Quality Engineer, Quality Operations, location in Jacksonville, FL. The Senior Software Quality Engineer is primarily responsible to manage the development & implementation of software validation policies and procedures. They will manage and conduct software validation projects in support of existing computerized systems in the Jacksonville campus. Project responsibilities will be focused on medium to large validation projects. This position may also oversee software qualification activities related to contract repackaging and contract manufacturing projects.

Requirements

• Minimum 6 industry experience working in medical device and/or pharmaceutical manufacturing, with a degree in Computer Science, Life Science, or software engineering. ( 4 year minimum for Master degree).
• Excellent understanding and application of principles, concepts and practices of Software validation methods, ISPE/GAMP 5, QSR/ISO regulations.
• Experience developing validation policies/ procedures/ guidance.
• Excellent organizational, interpersonal, written, and analytical, and oral communication skills required.
• Comprehensive understanding and demonstration of principles and concepts within Process Excellence, Statistical Process Control and Applied Statistics.
• Data driven.
• Ability to handle multiple projects simultaneously and to discern major quality issues.
• Bachelor’s Degree - Science/Engineering/Business

Nice To Haves

• Preferred validation experience.
• Minimum 2-year experience with SCADA and/or Manufacturing control systems
• Certified Software Quality Engineer ( CSQE) certification from ASQ preferred.
• Master’s degree preferred.

Responsibilities

• Facilitates and leads software validation activities/projects with specific focus to manufacturing systems.
• Creates, reviews and/or approves software validation documentation. Ensures all activities are consistent with regulations and validation policies and procedures. ( 50%)
• Supports the global streamlining and standardization of SDLC & software validation policies, procedures and processes for computerized systems. Implements new or re-engineered software validation systems/ programs. Establishes “live documents” process and remediation of legacy systems. (20%)
• Reviews and approves internal and vendor software development and test documentation, and conducts software vendor audits as needed. (5%)
• Applies a risk-based approach to validation strategy and evaluate change request assessments ( 5%)
• Develops and conducts SDLC/CSV training for IT and Operations. (10%)
• Review and support updates to software based quality documentation and procedures. (5%)
• Performs other related duties as assigned by management. (5%)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees