Validation Specialist
2 days ago
ACL Digital is seeking a skilled Validation Engineer to join our team.
About the RoleWe are looking for a highly motivated and experienced Validation Engineer to support the qualification of Analytical Laboratory Instrumentation. The ideal candidate will have a strong background in validation and qualification of computerized analytical instruments, with a focus on software compliance and data integrity.
Key Responsibilities- Assess instrument software for compliance with 21 CFR Part 11, Annex 11, and data integrity requirements.
- Develop validation deliverables in collaboration with cross-functional teams.
- Execute protocols and develop validation summary reports.
- Review vendor-executed protocols to ensure instrument qualification meets intended use.
- Ensure instrument systems are validated per their intended use and meet data integrity and data security requirements.
- Assess, author, implement, and close change management requests related to qualification, relocation, requalification, upgrade, and decommissioning.
- Prepare regulatory submissions and present validation documentation to regulatory authorities.
- Bachelor's degree in a relevant field.
- 5+ years of experience in a relevant or related field.
- Experience with Pharmaceutical/Biotechnology clients is strongly recommended.
- Strong team player with excellent communication and problem-solving skills.
ACL Digital offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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Biologics Validation Specialist
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Quality Assurance Specialist
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