Johnson & Johnson, Vision Jacksonville, FL is seeking a Senior Software Validation Quality Engineer to manage the development and implementation of software validation policies and procedures, and to conduct software validation projects for existing computerized systems.
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). Preferred validation experience.
- Minimum 2-year experience with SCADA and/or Manufacturing control systems
- 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.
- Comprehensive understanding and demonstration of principles and concepts within Process Excellence, Statistical Process Control and Applied Statistics. Data driven.
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.
- 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.
- Reviews and approves internal and vendor software development and test documentation, and conducts software vendor audits as needed.
- Applies a risk-based approach to validation strategy and evaluate change request assessments
- Develops and conducts SDLC/CSV training for IT and Operations.
- Review and support updates to software based quality documentation and procedures.
Other
- Works independently on complex issues; serving as a subject matter expert within functional area.
- Resolves difficult technical issues. Prioritizes tasks to meet deadlines. Suggests and implements tactical direction for functional area.
- 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.
- Contributes to the functional milestones associated with specific projects. Contributes to cross-functional teams.
- Bachelor’s Degree - Science/Engineering/Business
- Master’s degree preferred.
- Excellent organizational, interpersonal, written, and analytical, and oral communication skills required.
- Ability to handle multiple projects simultaneously and to discern major quality issues.
