Validation Engineer, Valgenesis
4 weeks ago
Validation Engineer, Valgenesis
Foster City, VA
Length: year to start, likely extensions
Responsibilities
- Validation Plans and Change Controls for Valgenesis project
- Validation testing strategy in accordance with client's policy and procedures
- closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement Valgenesis projects
- with understanding the business requirements, analyze and help translate into functional requirements for assigned Valgenesis projects
- closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using Valgenesis application
- review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for Valgenesis projects
- for Qualification protocols execution and final report view and approval for Valgenesis projects
- "Data Integrity” related- risk assessments,
- investigations suggest implementing remediations in CGMP operations.
- Data Integrity compliance/impact assessments, risk assessments, and create short executive summary reports.
- with the external partner or internal site to assess their DI maturity state and document the results of the assessment.
Required Experience / Skills:
- of 6-10+ years of experience (Hiring for multiple roles Junior, Mid and Senior levels) working on a Valgenesis application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.
- knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.
- to master technical content through interaction with subject matter experts.
- communication and interpersonal skills.
- Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.
- of programming and relational database concepts is required.
Required Education:
BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.
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