Senior Validation Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

Johnson & Johnson, Vision a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Validation Quality Engineer, Quality Operations. This position will be located in Jacksonville, FL

Position Summary:

The Senior Quality Engineer is primarily responsible for ensuring operational compliance to FDA/GMP and ISO 9001 regulations. Analyzes quality trends and reports conclusions. Reviews and applies trend results to prioritize resolution of process, equipment and/or system problems in order to prevent re-occurrence. Utilizes tools to track quality performance and identify key opportunities. In addition, the Sr. Quality Engineer provides support in the planning, development, implementation, and maintenance of the quality management systems, policies, documentation, data and processes.

Key Responsibilities:

• Facilitates complex validation activities within product, process, equipment, software and facilities changes and ensures all activities are consistent with regulations and validation policies and procedures. ( 30%)

• Utilizes quality tools to track and trend quality performance and identify key opportunities for improvement. Applies trend results to help prioritize the resolution of equipment, systems or processes to prevent recurrence. (15%)

• Applies a risk-based approach to validation strategy and evaluate change request assessments ( 10%)

• Represents quality assurance in validation for multi-departmental meetings, change control, and project teams as needed. (10%)

• Compiles data and provides reports to management on a periodic basis. (10%)

• Formulates quality policies and procedures and conducts training on quality concepts and tools and systems as necessary (5%%)

• Review and support updates to quality documentation and procedures. (5%)

• Develops sampling plans by applying attribute, variable, and sequential sampling methods. (5%)

• Performs other related duties as assigned by management. (10%)

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. 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 - 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.

Qualifications:
Education:

Bachelor’s Degree - Science/Engineering/Business

Master’s degree preferred.

Experience and Skills:

5-9 years industry experience working 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/FDA regulatory requirements

Excellent organizational, interpersonal, written, and oral communication skills required.

Root cause analysis experience required. 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.

…