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Accountabilities:
- Lead validation initiatives and develop reusable frameworks for computer system validation and computer software assurance.
- Establish validation strategies aligned with cGxP, GAMP 5, EU Annex 11, 21 CFR Part 11, and ALCOA+.
- Mentor junior consultants and support the growth of the consulting practice.
Requirements:
- 10+ years of experience in CSV/CSA within life science manufacturing environments.
- Strong knowledge of regulatory standards including cGxP, GAMP 5, 21 CFR Part 11, and ISO 13485.
- Excellent technical writing skills with experience producing inspection-ready documentation.
Benefits:
- Competitive compensation package with full-time remote work.
- Comprehensive medical, dental, and vision benefits.
- 401(k) retirement plan with employer match and generous paid time off.
Unknown
The company is a consulting firm that provides validation and compliance services for life science manufacturers. They have a people-focused culture with opportunities for professional development and growth.