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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.

Key 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%)

Quality Leadership Development Common Skills:

Master’s Complexity - Works independently on complex issues; serving as a subject matter expert within functional area. Technical expert for job function; conceptual understanding of all responsible functions and business areas.

Innovation - Resolves difficult technical issues. Prioritizes tasks to meet deadlines. Suggests and implements tactical direction for functional area. Uses a systematic approach to solving problems; Researches and benchmarks creative solutions.

Customer Focus - Meets customer service requirements by developing the basic work assignments and tactical plans to get the work done, and/or, contributes expertise to programs and projects.

Interdependent Partnering - Contributes to the functional milestones associated with specific projects. Contributes to cross-functional teams. Provides a higher level of technical and relational contribution than found in lower levels and may serve in a project leadership role. Utilizes effective mediation/conflict management, negotiation, and internal/external influencing skills. Identifies and resolves relationship issues.

Organizational & People Development - Coaches and guides technical staff. May have formal responsibility/input for performance development. May supervise contractors. Trains new employees. Influences day-to-day harmony within the group. Recommends and supports technical and process improvements.

Education:

Bachelor’s Degree - Science/Engineering/Business

Master’s degree preferred.

Experience and Skills:

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

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https: //www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.