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Staff Computer System Validation Specialist

2 months ago

Danvers, Massachusetts, United States Johnson and Johnson Full time
Job Title: Staff Computer System Validation Specialist

Johnson & Johnson is seeking a highly skilled Staff Computer System Validation Specialist to join our team. As a key member of our MedTech organization, you will be responsible for ensuring the validation of computer systems and software applications used within Abiomed.

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.
Requirements:
  • 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.
  • 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of 21 CFR Part 11 / EU Annex 11 and other relevant regulatory requirements such as ISO 13485, 82304, FDA CSA Draft Guidance.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 Qualifications:
  • 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.
Additional Information:

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.