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.