Johnson & Johnson

Senior Software Quality Engineer

Johnson & Johnson • $90K — $120K *
Jacksonville, FL 32210In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
4 days ago
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Job Overview by Ladders

Qualifications

  • Bachelor’s Degree in Engineering, Computer Science, or related STEM field.
  • 6+ years of experience in a regulated environment, preferably in Medical Device or Pharmaceutical industry.
  • Knowledge of software validation requirements for medical device production and quality systems.
  • Familiarity with FDA and European medical device regulations (QSR and ISO).
  • Understanding of GAMP5 and software development life cycle (SDLC).
  • Knowledge of Part 11 regulations for electronic records and data integrity.
  • Experience with SCADA, PLC, HMI, Vision Systems, and/or Manufacturing Execution Systems.

Responsibilities

  • Support Computer Software Validation (CSV) project planning activities.
  • Review and approve key software validation documentation.
  • Coordinate validation activities with Engineering, Operations, and R&D teams.
  • Act as the SQE representative in the Change Control Board (CCB).
  • Assist with the Installation Qualification (IQ) for manufacturing lines.
  • Contribute to CSV program improvements and compliance initiatives.
  • Participate in audit readiness and support investigations for CSV audit observations.

Benefits

  • Opportunity to work with a leading company in the medical device sector.
  • Collaborative work environment with cross-functional teams.
  • Engagement in critical projects from planning to execution.
  • Potential for professional development and certifications within Quality Assurance.
  • Flexible travel opportunities for professional exposure.
Full Job Description
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 Care, a member of Johnson & Johnson Family of Companies, is currently seeking a Senior Software Quality Engineer, to join our outstanding team located in Jacksonville, FL!

In this role the Sr. Software Quality Engineer applies tools and practices for the effective and efficient development, transfer, and maintenance of manufacturing processes throughout the product lifecycle.

The Sr. Software Quality Engineer conducts assignments encompassing complete projects or portions of major projects. By determining methods and techniques to be used, will coordinate phases of work internally and externally.

Key Responsibilities:

  • Support Computer Software Validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents.
  • Review and approve software validation documentation, such as qualification protocols, reports, software test scripts, risk analysis, and code reviews.
  • Work multi-functionally with Engineering, Operations, R&D and other groups to plan and complete validations on current and new processes for operational integration.
  • Facilitate software changes as part of the Change Control Board (CCB) as the SQE representative.
  • Support the Installation Qualification (IQ) of manufacturing lines.
  • Support CSV programs / policies / procedures and improvement initiatives for computerized systems.
  • Support compliance activities by participating in audit readiness, and internal and external audits pertaining to CSV.
  • Support investigations, responses, and remediation of site-specific CSV audit observations.

Qualifications

Education:

  • A minimum of a Bachelor’s Degree in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.

Experience and Skills:

Required:

  • A minimum of six (6) years of experience in a regulated environment (Medical Device or Pharmaceutical Industry experience is preferred).
  • Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System
  • Working knowledge of FDA and European medical device regulations (QSR and ISO)
  • Working knowledge of GAMP5 and SDLC
  • Working knowledge of Part 11 regulations for electronic records, electronic signatures, and data integrity
  • Experience with SCADA, PLC, HMI, Vision Systems, and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations
  • Experience with change control
  • Effective technical writing and verbal communication skills
  • Knowledge of non-conformances, root cause investigations, corrective and preventative actions

Preferred:

  • Experience in medical device IQ, OQ, and PQ process validation
  • Experience in Quality Auditing and notified body inspections
  • Software Quality Engineer certification (CSQE) or Quality Engineer certification (CQE)

Other:

  • This position may require up to 10% domestic or international travel.

 

Required Skills:

 

 

Preferred Skills:

About Johnson & Johnson

Scio Diamond creates single-crystal Type IIa diamonds for the jewelry market and for industrial applications. It employs a patent-protected chemical vapor deposition (CVD) process in a precisely controlled laboratory setting to produce diamonds. It was founded in 2009 and is headquartered in Greenville, South Carolina.

Johnson & Johnson Careers

Joining Johnson & Johnson provides an unparalleled opportunity to be a part of a global team of professionals dedicated to blending care, science, and innovation to profoundly change the trajectory of health for humanity.

Work You’ll Do

At Johnson & Johnson, you will engage in work that matters. Join our community of professionals in health care to drive significant and impactful changes across the globe. Our team at Johnson & Johnson leads with science and heart in sectors from pharmaceuticals to medical devices and consumer health products.

Transform Health Care

Leverage Johnson & Johnson’s culture of innovation to transform health care and improve the lives of people around the world. Our collaborative environment encourages leadership and growth, allowing you to pioneer new strategies for health care solutions with a diverse team of experts.

Innovative Work

Engage in groundbreaking work that enhances how care is delivered on a global scale. Johnson & Johnson’s commitment to innovative health solutions results in dynamic career paths filled with opportunities for professional growth and development.

Be Part of a Great Team

Our team at Johnson & Johnson thrives on collaboration and diversity. You will work alongside over 130,000 employees globally who are committed to making a lasting impact. With a culture that values diversity training and leadership, you are supported in both personal and professional growth.

Future-Proof Your Career

Johnson & Johnson offers a myriad of job opportunities and employment benefits designed to help you meet your career and personal goals. Our employees enjoy comprehensive benefits, including health insurance, retirement plans, and family-friendly policies that pave the way for a fulfilling career and life balance.

Explore Job Opportunities and Internships

Whether you’re looking to start your career or take it to the next level, Johnson & Johnson offers positions ranging from internships to leadership roles across various sectors. Enhance your skills through hands-on experience and our extensive networking and mentorship programs.

Johnson & Johnson Leadership and Development

Our commitment to leadership and continuous learning is at the core of our employment philosophy. Every position offers chances to lead, learn, and innovate. We provide extensive training programs and development courses that prepare you for the future of health care.

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Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at Johnson & Johnson. Join Johnson & Johnson today to be a part of a team that values innovation, leadership, and diversity, and see how far your ambition can take you.
Learn more about Johnson & Johnson
Size
141,700 employees
Market Cap
$462.7 billion
Industry
Pharmaceuticals & Biotech
Net Income
$14.7 billion
Founded
1886
5 Year Trend
+5.5%
Revenue
$82.5 billion
NASDAQ
JNJ
* Ladders Estimates

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