Staff Computer System Validation (CSV) Engineer

Company: Disability Solutions
Location: Danvers
Posted on: September 25, 2024

Job Description:

Johnson & Johnson Abiomed is recruiting for a Staff Computer System Validation (CSV) Engineer. This position can be based at any Abiomed site in the United States. Remote work options may be considered on a case-by-case basis and if approved by the company.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.At Johnson & Johnson MedTech (MT) Companies, we use technology and the power of collaboration to discover new ways to prevent and overcome the world's the most significant healthcare challenges. MedTech Quality Systems organization leverages modern technology solutions, data, real-world insights, and creative minds to support development of life-changing products. We're disrupting traditional way of working by infusing our existing best practice with transformative ideas to help MT businesses thrive throughout every stage product lifecycle and deliver the highest quality experiences for our patients, consumers, and customers in an increasingly connected and personalized world.The Staff CSV Engineer will be responsible for ensuring that all computer systems and software applications used within Abiomed are validated according to industry standards, regulatory, and Johnson & Johnson MedTech requirements. The role involves collaborating with cross-functional teams, conducting validation activities, documenting procedures, and maintaining compliance records.Key Responsibilities:

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• Develop and execute Abiomed's integration plan for CSV to assess, plan, and enhance Abiomed's CSV processes and execution in alignment with the rest of J&J MedTech.
• Work as an SME and liaise between J&J MedTech QS/DS COE organization and Abiomed to enable consistent CSV execution and provide SME support at Abiomed.
• Develop and execute validation plans for new and existing GxP computer systems and digital solutions.
• Support Validation Master Plan (VMP) at Abiomed sites to ensure VMP requirements are fulfilled.
• Lead and/or Perform various SDLC and Software V&V activities such as Requirements Analysis, Validation Plan & Report, testing, qualification, and other relevant and required activities.
• Create and maintain validation documentation, such as test protocols, reports, and risk/compliance assessments.
• Conduct audits and/or periodic review of validated systems to ensure compliance with regulatory requirements
• Provide technical and SME support to owners and users of validated systems
• Work with other members of the QA team to develop and implement quality improvement initiatives\r\r

Keywords: Disability Solutions, East Providence , Staff Computer System Validation (CSV) Engineer, IT / Software / Systems , Danvers, Rhode Island