Johnson & Johnson Vision Care, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Senior Quality Engineer located in Jacksonville, Florida.
Johnson & Johnson Vision Care (“JJVC”) specializes in disposable contact lenses, which it markets under ACUVUE® Brand Contact Lenses. Ever since the ACUVUE® Brand transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUE® lenses are worn by more people than any other brand.
The Senior Quality Engineer ensures quality and validation programs are well-defined, executable, meets customer and business needs, and are in compliance with regulatory requirements. Implements global programs/policies/procedures with respect to Validation, Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management.
Proactively examines systems, processes, and standards to identify areas for review, change, or elimination. Establishes linkages to other quality systems/programs like Technology Transfer, Change Management, Test Method Transfer, and CAPA.
Manages validation projects in support of existing products/processes and propagations of new products at the Jacksonville campus. Project responsibilities will be focused on process improvements, large to multi-site validation projects with process characterization, and DOEs. This position may also oversee qualification activities related to contract repackaging and contract manufacturing projects.
Validation responsibilities include, but not limited to the following:
• Prioritizing and planning all assigned projects for the QA validation department
• Creating master validation plans and schedules
• Leading validation project planning
• Facilitating risk analysis
• Perform/review failure investigations
• Documenting & executing qualification protocols and reports
• Facilitating change validation
• Supporting raw materials, formulations, and facilities qualifications
Supporting/executing DOEs and process characterization studies
• Developing validation training modules
• Implementing new or changed quality systems (programs/policies/procedures)
• Conducting validation and statistics training for Operations, QA, IT, and MSE personnel.
• Develops, enhances, and implements validation programs/policies and procedures for manufacturing equipment/process and computerized (automated) systems, including training programs.
• Leads validation activities/projects. Creates reviews and/or approves software, equipment, facilities, formulations, and product/process validation documentation, including site validation master plan.
• Implements programs/policies/procedures with respect to Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management.
• Proactively examines systems, processes, and standards to identify areas for review, change, or elimination. Establishes linkages to other quality systems/programs like Technology Transfer, Change Management, Test Method Transfer, and CAPA.
• Provides consulting, training and guidance on validation principles, risk management, root cause analysis, statistics, and quality systems.
• Perform other related duties as assigned by management. Qualifications
• A minimum of a Bachelor's degree is required; a degree in a technical field is preferred; an advanced degree is an asset.
• Minimum 4 years work experience in Validation/Statistics/Process Engineering/Test Method Development within the Medical Device and/or Pharmaceutical industries required.
• Certified Quality Engineer (CQE) certification is preferred
• Excellent understanding and application of principles, concepts and practices of Risk Management, Statistical Methods, Validation, Commissioning & Qualification, Root Cause Analysis/Failure Investigation, and the QSR/ISO Regulation is required
• Excellent communication, interpersonal, conflict management, and organization skills is required. Strong leadership and coaching skills is required.
• Proven ability to manage by influence, especially in leading change required.
• Ability to work in a cross functional environment is required.
• Excellent verbal and written communication skills as well as superior analysis and problem identification skills is required.
• This position may require up to 10% domestic and international travel and will be based in Jacksonville, Florida. Primary Location
Johnson & Johnson Vision Care, Inc. (6094)Job Function