Senior Validation Quality Engineer

Johnson & Johnson•Jacksonville, FL

7d•Onsite

About The Position

Johnson & Johnson Vision, a member of the Johnson & Johnson Family of Companies, is recruiting a Senior Validation Quality Engineer for Quality Operations in Jacksonville, Florida. The role is primarily responsible for ensuring operational compliance with FDA/GMP and ISO 9001 regulations, analyzing quality trends, reporting conclusions, and using trend results to prioritize resolution of process, equipment, and system problems to prevent recurrence. The position also supports planning, development, implementation, and maintenance of quality management systems, policies, documentation, data, and processes. The role works independently on complex issues and serves as a subject matter expert within its functional area. It may involve project leadership, coaching and guiding technical staff, training new employees, recommending process improvements, and supervising contractors. The position represents Quality Assurance in validation-related work and collaborates across departments and project teams.

Requirements

Bachelor’s degree in Science, Engineering, or Business.
5–9 years of industry experience in medical device and/or pharmaceutical manufacturing, Quality Assurance, or Regulatory fields.
In-depth understanding and application of principles, concepts, and practices of production manufacturing, sterilization, and Quality Assurance procedures.
Thorough knowledge of ISO and FDA regulatory requirements.
Excellent organizational, interpersonal, written, and oral communication skills.
Root cause analysis experience.
Ability to recognize and resolve technical issues.
Comprehensive understanding and demonstration of principles and concepts within Process Excellence, Statistical Process Control, and Applied Statistics.
Data-driven approach and ability to organize and analyze data.
Ability to handle multiple projects simultaneously and discern major quality issues.

Nice To Haves

Master’s degree preferred.

Responsibilities

Facilitate complex validation activities involving product, process, equipment, software, and facilities changes, ensuring consistency with regulations and validation policies and procedures.
Use quality tools to track and trend performance, identify improvement opportunities, and apply trend results to prioritize resolution of equipment, system, or process issues and prevent recurrence.
Apply a risk-based approach to validation strategy and evaluate change request assessments.
Represent Quality Assurance in validation for multidisciplinary meetings, change control, and project teams as needed.
Compile data and provide periodic reports to management.
Formulate quality policies and procedures and conduct training on quality concepts, tools, and systems as necessary.
Review and support updates to quality documentation and procedures.
Develop sampling plans using attribute, variable, and sequential sampling methods.
Perform other related duties as assigned by management.
Coach and guide technical staff, train new employees, and recommend and support technical and process improvements.