Principal Software Quality Engineer
Johnson & Johnson Vision Care, Inc. - Jacksonville, FL

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2576120815

Description

Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies is recruiting for Principal Software Quality Engineer, to be located in Jacksonville, Florida.

Johnson & Johnson Vision Care, Inc., - Vistakon® Division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUE® Brand contact lenses. Ever since ACUVUE® 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 Principal Software Quality Engineer functions as an expert in Computer Systems Validation (CSV) principles. Works closely with R&D, IT, engineering, manufacturing operations, and other stakeholders in creating and delivering innovative and compliant software validation approaches for day-to-day support and emerging business needs. As a primary responsibility, directs all aspects of the software quality sub system ensuring that all requirements under the organization are met.

The Principal Software Quality Engineer leads and manages multiple software validation projects by developing and delivering on the strategy related to the verification/qualification of facility, utilities, manufacturing and process support equipment and associated computer systems. Partner with project teams to implement qualification strategy utilizing Good Engineering Practice (GEP). 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 Software Validation, Revalidation, Commissioning & Qualification of Hardware Systems, Root Cause Analysis/Failure Investigations, and Risk Management.

Performs a variety of Computerized System Validation (CSV) assignments at an advanced technical expertise level utilizing a wide range of Industry CSV techniques and principles: project leadership, computerized system requirement and development of CSV programs and associated training. Leads on validation protocols, test plans and reports.

Has thorough understanding of System Development Life Cycles for FDA regulated applications. Develops Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports. Has thorough knowledge of US CFR 21 Part 11, part 820 regulations and/or ISO13485

Is experienced with high volume application testing environments. Has a strong PLC background in Siemens S7, APT, Allen Bradley Control Logix 5000, Pilz Safety PLCs and Wonderware Intouch/ArchestrA HMI software. Experience in Automation Equipment, using PLCs, HMI, SCADA systems, Batch control. Experience with Enterprise level software systems, MRP, MES Systems, peer to peer communication.

Prepares, reviews and approves project documentation including site validation master plan, monitors and evaluates changes to validated computerized systems. Develops procedures associated with engineering qualification of equipment and software. In addition to software and hardware validations, this position may also oversee qualification activities related to repackaging and manufacturing projects.

Directs, leads, manages, review progress and evaluate status of multiple company projects within the CSV area of responsibility. Delegates activities of SQE's and contractors as necessary for completion of projects and reports project status to management.

Is knowledgeable of printer systems, vision systems, robotics, BCR, RFID systems and with automated Software Testing tools is an asset. Have some understanding of Sarbanes-Oxley (SOX) regulations is required.

Quality Leadership Development Common Skills:
Masters Complexity

  • Defines and implements department or division strategies, and serves as an authority to the business. Establishes and has accountability for technical standards for department and division. Understands and maintains the interrelationships among functions and with other business areas. Serves as technical representative for department.
Innovation

  • Identifies and manages risks and business needs. Ensures the development and implementation of leading edge quality systems and practices internally/across sites/companies.
Customer Focus

  • Develops and ensures departmental or divisional initiatives maximize customer value at lowest cost.
Interdependent Partnering

  • Sponsors departmental and cross-functional team development. Removes barriers. Provides project leadership or participates as a team member on major initiatives that have high impact to the business. Key member of leadership team. Applies influence across departments and the business.
Organizational & People Development

  • Accountable for organizational depth to meet present and future business needs, looking across J&J companies. Serves as a change agent for global effectiveness.
Adheres to environmental policy and procedures and supports department environmental objectives.

Manages, plans, conducts, leads, multiple CSV projects of significant magnitude across various disciplines involving the use of Computerized Systems with considerable latitude for action or decision. Utilizes a wide range of engineering principles and works with advanced technical expertise, to lead validation activities. (60%)

Validation responsibilities include, but not limited to the following:

Prioritizing and planning all assigned projects for the QA validation department

Leading validation project planning

Facilitating risk analysis

Perform/review failure investigations

Preparing & executing qualification protocols, test plans, and reports

Facilitating change validation

Reviewing and approving project documentation

Monitoring and evaluating changes to validated computerized systems.

Supporting testing labs, formulations, and facilities qualifications

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.

Assisting with coordination of activities of team members and/or Contractors as necessary for completion of projects.

Provides leadership, guidance and training of CSV and validation programs, principles, risk management, root cause analysis, statistics, quality systems and Good Engineering Practice (GEP) policies and procedures for facility, utilities, manufacturing process equipment and associated computerized (automated) systems and software (10%)

Develops, enhances, and implements software validation programs/policies and procedures for manufacturing equipment/process, programs/policies/procedures with respect to Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management. (10%)

Proactively monitors and examines systems, processes, and standards to identify areas for review, improvement, change, or elimination. Establishes linkages to other quality systems/programs like Technology Transfer, Change Management, Test Method Transfer, and CAPA. (10%)

Reviews and approves vendor equipment and software development and test documentation. (5%)

Performs other related duties as assigned by management. (5%)

Qualifications

Bachelors Degree - Engineering/Computer Science 9year working in Industry.

Masters Degree - Engineering/Computer Science or Professional Association

Membership in IEEE, ISPE and ASQ encouraged.

The ideal candidate will have 5+ years experience working in Computerized System Validation within Medical Device or Pharma industry.

Excellent communication, interpersonal, organizational and analytical skills.

Thorough knowledge, understanding and application of principles, concepts and practices of GMP/ISO regulations.

Excellent mentoring, coaching skills is a requirement. Technical Leadership skills are required for this role.

The Principal Software Quality Engineer will be required to lead and manage multiple software validation projects by developing and delivering on the strategy related to the verification/qualification of facility, utilities, manufacturing and process support equipment and associated computer systems. Has thorough understanding of System Development Life Cycles for FDA regulated applications. Develops Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports. Has thorough knowledge of US CFR 21 Part 11, part 820 regulations and/or ISO13485.

This engineer is experienced with high volume application testing environments. Has a strong PLC background in Siemens S7, APT, Allen Bradley Control Logix 5000, Pilz Safety PLCs and Wonderware Intouch/ArchestrA HMI software. Experience in Automation Equipment, using PLCs, HMI, SCADA systems, Batch control. Experience with Enterprise level software systems, MRP, MES Systems, peer to peer communication. Is knowledgeable of printer systems, vision systems, robotics, BCR, RFID systems and with automated Software Testing tools is an asset. And will have some understanding of Sarbanes-Oxley (SOX) regulations is required.

This position may required up to 20% travel both domestic and international.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location

North America-United States-Florida-Jacksonville

Organization

Johnson & Johnson Vision Care, Inc. (6094)

Job Function

Quality (Eng)

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