Validation Analyst
100% remote (EST work hours)
6+ month project
Duties and Responsibilities:
- Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, or processes.
- Perform risk assessments and define validation strategies based on system impact.
- Document validation activities in accordance with regulatory standards (e.g., FDA, EMA, GxP, 21 CFR Part 11).
- Collaborate with cross-functional teams (QA, IT, Manufacturing, Engineering) to gather requirements and ensure validation readiness.
- Support audits and inspections by providing validation documentation and responses.
- Maintain validation lifecycle documentation including validation plans, reports, deviations, and change controls.
- Track and manage validation deliverables and timelines for projects.
- Stay current with industry best practices and regulatory changes
Required Skills/Certifications:
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
- Experience in validation (equipment, process, software, or computer systems).
- Familiarity with regulatory guidelines (GxP, 21 CFR Part 11, Annex 11, etc.).
- Strong analytical, documentation, and problem-solving skills.
- Attention to detail and ability to manage multiple validation projects.
- Excellent communication and organizational skills
Preferred Skills/Certifications:
- Experience with computerized system validation (CSV).
- Knowledge of validation in regulated environments (e.g., pharmaceutical, biotech, medical devices).
- Proficiency in validation tools and documentation software.
- Relevant certifications (e.g., ISPE, ASQ, or CSV certifications).
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Spectraforce Technologies
May 06, 2025