Azenta Inc. is seeking a Quality Engineer to manage the preparation and execution of validation protocols for GxP/regulated processes, software, laboratory equipment, and methods. The role involves ensuring compliance with regulatory requirements and industry best practices for validation activities.
Requirements
- Previous software validation experience is required.
- 3+ years’ experience working in GxP/ regulated environment
- Experience with validation protocols (IQ/OQ/PQ) for environmental monitoring system or ultra-cold storage.
- Working knowledge of 21CFR Part 11, EU Annex 11, UK MHRA and other data integrity regulations
- Working knowledge of CAP, ISPE, GAMP, and ICH guidelines
- Experience writing technical documents and a high level of Microsoft Word and Excel expertise.
- Strong analytical skills and the ability to think creatively.
Responsibilities
- Manage preparation and execution of validation protocols for GxP/regulated processes, software, laboratory equipment and methods.
- Writing protocols, reports, and compiling data and attachments into comprehensive validation packages.
- Assisting with the development of requirements, procedures, specifications, validation master plans and other validation related documentation.
- Manage and coordinate the preparation, review, and approval of validation plans.
- Manage and coordinate the preparation, review and issuing of validation protocols and reports.
- Manage and coordinate validation documentation including risk assessments, traceability matrices, and validation reports.
- Manage and coordinate the review and approval of requirements and specifications associated with Equipment, Processes, and Computerized Systems.
Other
- Four-year degree, preferred in Life Sciences, Computer Science or Engineering.
- 5+ years relevant experience in validation.
- Experience with contributing to multiple projects with dynamic deadlines
- Excellent leadership skills and ability to work across organization.
- Self-directed with a high degree of professional integrity, organization, and attention to detail.
