Job Details

Responsibilities:

• Lead and manage CSV (Computer System Validation) for GxP systems across Quality, Manufacturing, Clinical, and Business areas.
• Develop and maintain validation procedures, templates, and master validation plans.
• Prepare and review validation documentation (plans, protocols, reports).
• Ensure compliance with GAMP 5, 21 CFR Part 11, and ISO 13485.
• Collaborate with cross-functional teams (IT, QA, Engineering, Manufacturing, Clinical).
• Support change control, audits, CAPA, and document control processes.
• Mentor junior team members on data integrity and validation best practices.

• Bachelor's degree in engineering, Computer Science, IT, or Life Sciences.
• 6+ years of experience in medical device or regulated industry; 3+ years in software validation.
• Strong knowledge of GAMP 5, Part 11, Annex 11, and cloud/SaaS validation.
• Proficiency in Microsoft Office, Google Suite, Jama, eQMS/ePLM.
• Excellent communication and teamwork skills.
• Preferred Certifications: GAMP Practitioner, PMP, ASQ-CQA.