Validation Engineer, Labware LIMS

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.