Staff Computer System Validation (CSV) Engineer - Johnson and Johnson

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:

• 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

Education:

• University/Bachelor or equivalent degree is required; a degree concentration in Computer Science, Engineering, Life Sciences, Data Science or other relevant subject area will be an asset.

Experience and Skills
Required:

• Four to six (4-6) years of related experience
• Experience in computer system validation in MedTech or Pharma
• Strong understanding of 21 CFR Part 11 / EU Annex 11 and other relevant regulatory requirements such as ISO 13485, 82304, FDA CSA Draft Guidance
• Excellent analytical and problem-solving skills
• Ability to work independently and as part of a team

Preferred:

• Experience with validation software tools such as Jira, Xray, qTest, HP ALM.
• Experience with other Compliance Requirements such as Security, Privacy, Record, Localization.
• Experience with auditing or periodic/independent quality review of digital solutions or computerized systems.
• Experience with data integrity requirements and implementation

Other:

• Up to 10% travel, domestically and internationally is required.
• The anticipated base pay range for this position is $90,000 to $144,900.
• The anticipated base pay range for this position, in the Bay Area, is $105,000 to $166,635.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .