Senior Software Quality Engineer

Johnson & Johnson-posted 2 days ago
Full-time • Mid Level
Onsite • Jacksonville, FL
5,001-10,000 employees
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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.

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