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