Johnson & Johnson Careers
Senior Software Quality Engineer
Requisition ID: 3243190501
Johnson & Johnson Vision (JJV), a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Software Quality Engineer to be located in Jacksonville, FL.
JJV, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the JV brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Manage/conduct software validation projects in support of new and existing computerized systems in the Jacksonville campus. Manage the development & implementation of software validation policies and procedures. Project responsibilities will be focused on medium to large validation projects. This position may also oversee software qualification activities related to contract repackaging and contract manufacturing projects.
Responsibilities include, but not limited to the following:
- Leading software validation project planning and execution
- COTS package evaluations
- Requirements gathering
- Performing software risk assessments
- Providing guidance and quality reviews / approvals for qualification plans, protocols & reports, software test cases/scripts, code reviews, software requirements and design, and software risk assessments, among others.
- Reviewing/approving software vendor package documentation
- Prioritizing and planning all assigned projects for the QA software validation department
- Implementing new or changed quality systems (programs/policies/procedures)
- Leading the quality aspects of the design/development of computerized systems
- Facilitating change validation as part of the Change Control Board (SQE representative)
- Developing CSV training modules and provide CSV training globally to Operations, QA and IT.
- Leading the Installation Qualification (IQ) of fully automated, high speed manufacturing lines
- Supporting CSV improvement initiatives
CAPAs, drive root cause investigations and corrective actions determinations
for issues related to software quality.
This position will also monitor/evaluate changes to validated computerized systems and audit software vendors as needed. This Sr. SQE will lead the streamlining and standardization of Vision Care’s Computerized Systems Validation (CSV) and SDLC programs globally, which includes links to OPS/IT/R&D business practices, 21 CFR Part 11 and data integrity, software risk assessments, Business Continuity, Change Management, and periodic reviews / revalidations, to align with Vision Care’s World Class Compliance Plan. The Sr. SQE will also support the remediation of legacy systems (per CSV/SDLC program) and support the “living documents” process for relevant CSV/SDLC documents. This position will also lead the development and implementation of CSV/SDLC training programs and provide CSV/SDLC training globally.
Adheres to environmental policy and procedures and supports department environmental objectives.
- Leads software validation activities/projects with specific focus to manufacturing systems. Provides quality direction and guidance, reviews and/or approves software validation documentation. (50%)
- Support the global streamlining and standardization of SDLC & software validation policies, procedures and processes for computerized systems. Implements new or re-engineered software validation systems/ programs. Establish “living documents” process and remediation of legacy systems. (20%)
- Reviews and approves internal and vendor software development and test documentation and conducts software vendor audits as needed. (5%)
- Develops and conducts SDLC/CSV training for IT and Operations. (10%)
- Monitors and evaluates changes to validated systems. (10%)
- Performs other related duties as assigned by management. (5%)
- Bachelor’s Degree in engineering, Computer Science, or Life Sciences. Master’s Degree preferred.
- Minimum 6 years work experience for Bachelor’s degree, minimum 4 years work experience for Master’s degree, with Validation focus within the Medical Device and/or Pharmaceutical Industries.
- Minimum 2 years work experience with SCADA/HMI, Programmable Logic Controls (PLCs), Machine Vision Systems, and/or Manufacturing Execution Systems.
- Pharmaceutical or Medical Devices experience preferred.
- Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) certification from ASQ preferred.
- Experience with HP ALM testing preferred.
- Excellent understanding and application of principles, concepts and practices of software validation methods, Systems Development Lifecycle, ISPE/GAMP 5, QSR/ISO regulations, US and international data integrity regulations and guidance.
- Excellent communication, interpersonal, analytical and organization skills.
- Strong leadership and coaching skills.
- Experience with developing validation policies/procedures/guidance.
- Under general supervision, works within established guidelines and has flexibility as to method, priority and timing of job duties. Requires moderate amount of initiative and judgment.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Johnson & Johnson Vision Care, Inc. (6094)