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Lead, J&J Technology Quality- Computer System Validation
West Chester, Pennsylvania; United States; New Jersey, United States
Requisition ID: 3834180220
Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Lead, J&J Technology Quality- Computer System Validation PLM /DM /LMS/ DC. This role can be located anywhere in the US, with a preference for New Jersey and Pennsylvania sites, including remotely.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc. was started within Ethicon, and was separated and moved to Cincinnati, Ohio over 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today along with innovative energy devices for surgery.
You, the Lead Quality Computerized System Validation (Q-CSV) Center Of Excellence ensures compliance of systems across the enterprise in accordance with J&J SDLC, assures compliance within the enterprise with applicable global regulations, advise on quality matters, and assist with closing compliance gaps related to audits and inspections.
- The Lead Q-CSV PLM/Document Management is responsible for supporting the project team through the day to day project activities under the supervision and direction of the Manager. The purpose of this role is to assist and work closely with the Project Manager for project planning and execution activities.
- The Q-CSV Lead is responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams.
- This position will support internal and external Health Authority regulatory audits. This position will be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use.
- Responsible for providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects
- Perform pre- and post-review and approval of validation test scripts including test defects. Review/approval of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use
- Ensure a high degree of Inspection Readiness for Systems in Q-CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within Q-CSV responsibility. Participate in audits, approves audit non-conformity action plans. Demonstrates an understanding of many relevant Quality and Compliance principles and their applications. Work with the Q-CSV Manager in developing, monitoring and managing project costs, schedules, resources and quality. Leads and mentors a team of internal and external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices. Assist or drive status meetings to communicate and address project risks or issues. Works collaboratively with project teams to keep them informed of project status, including any barriers
- Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same. Defines internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management. Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
- Provide an environment which encourages the company's credo and diversity of opinions and thoughts. Ensure timely completion of assigned training and expense reporting
- Collaborate with other leaders and staff within Q-CSV group to ensure each function is executed in an efficient manner. Ensure timely reports of status, metrics and time sheets as required by the Q-CSV organization. Ensure timely completion of assigned training and expense reports. Develop and maintain an effective working partnership with senior management. Perform other work-related duties as assigned.
- A Bachelor’s degree in Computer Science, Information Systems, Business Administration or other related field required; additional certifications a plus.
- A minimum of 6-8 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required.
- Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is required.
- Strong QA analyst skills with experience in Computerized System validation in GxP environments is required.
- Expert organizational skills are required. Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands.
- Must have the ability to work effectively in a highly matrixed systems environment.
- Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable.
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required.
- Experience in Testing Management Tools like HPALM is preferred.
- Validation experience with implementing PLM systems and other systems like LIMS, CAPA, MES, SAP, LMS, Complaints Handling, and Change Control is required.
- Superior written and oral communication and excellent Microsoft Office skills required.
- Knowledge of SDLC Quality Management process and Computerized System Validation principles is required
- Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding Quality.
- Certified Software Quality Engineer (CSQE), Certified Quality Engineer (SQE), Certified Quality Auditor (SQA), Project Management Professional (PMP) or similar.
- This position can be located anywhere in the US, including remotely and may require up to 30% domestic and international travel, depending on the location of the role.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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.
United States-Pennsylvania-West Chester
North America-United States, North America-United States-New Jersey
Ethicon Inc. (6045)