Senior Software Quality Engineer

J&J FAMILY OF COMPANIES

Jacksonville, Florida, United States of America
Software validation for manufacturing systems
Risk-based validation strategy
Software validation documentation management
Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation

Job Summary

  • Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation.
  • The Senior Software Quality Engineer manages the development and implementation of software validation policies and leads medium to large validation projects focused on manufacturing systems.
  • The role supports global standardization of SDLC and software validation processes and provides training for IT and Operations teams.

Matching Summary

Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation.

Skills & Requirements

Must-have

  • software validation for manufacturing systems
  • risk-based validation strategy
  • software validation documentation management
  • SDLC and software validation standardization
  • software vendor audits
  • SCADA and manufacturing control systems

Nice-to-have

  • coaching and guiding technical staff
  • process excellence and statistical process control
  • data driven decision making
  • cross-functional team collaboration
  • conflict management and negotiation skills

Key Requirements

  • Bachelor’s degree in Science, Engineering, or Business
  • Minimum 6 years industry experience in medical device or pharmaceutical manufacturing
  • Minimum 2 years experience with SCADA or manufacturing control systems
  • Certified Software Quality Engineer (CSQE) preferred
  • Master’s degree preferred
  • Experience with ISPE/GAMP 5 and QSR/ISO regulations

Work Rights

Not specified

Tailored Resume

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