Staftonic LLC
Validation Engineer – GxP Systems
Staftonic LLC, San Francisco, California, United States, 94199
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Staftonic LLC
Key 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. Qualifications
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. Seniority level
Mid-Senior level Employment type
Contract Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
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. Qualifications
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. Seniority level
Mid-Senior level Employment type
Contract Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr