Senior Validation Specialist
3 days ago
Job Title: Computer System Validation (CSV) Specialist
Remote: India - Only
Key Responsibilities:
- Develop and execute Abiomed's remediation activities for CSV, assessing, planning, and enhancing Abiomed's CSV processes and execution in alignment with J&J MedTech standards.
- Develop and execute validation plans for new and existing GxP computer systems and digital solutions.
- Lead and/or support various SDLC and Software V&V activities, including Requirements Analysis, Validation Plan & Report, testing, qualification, and other activities necessary to meet CSV deliverables.
- Create and maintain validation documentation, including test protocols, reports, and risk/compliance assessments.
- Conduct assessments and periodic reviews of validated systems to ensure compliance with regulatory requirements and Abiomed procedures.
- Provide CSV Subject Matter Expert (SME) support to system owners and users.
- Collaborate with other QA team members to support the development and implementation of quality improvement initiatives.
Education:
- University/Bachelor's degree or equivalent is required.
- Degree concentrations in Computer Science, Engineering, Life Sciences, Data Science, or related fields are an asset.
Experience and Skills Required:
- 4–6 years of related experience in computer system validation within MedTech or Pharma.
- Strong knowledge of 21 CFR Part 11, EU Annex 11, ISO 13485, ISO 82304, FDA CSA, MDSAP, and other relevant regulatory requirements.
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