Job Description

Labware LIMS CSV Engineer

We are looking for a Labware LIMS CSV engineer with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.

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 suggest technical solution for 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
• Qualification protocols execution and final report view and approval for LIMS projects
• Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects
• Learn and become proficient the EDMS (Electronic Data Management System), for document review and approval and ELMS (Electronic Leaning Management System) for documenting and performing assigned training.

Prepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:

• Standard Operating Procedures (SOPs)
• Work Instructions (WIs)
• Forms
• User Manuals / User Guides / User References / Quick Reference Guides and Training Material
• Training Plans
• Reference Documents
• Specifications
• Reports

Work independently but recognize the need to consult stake holders and keep them informed of progress.

Required Experience / Skills:

• Minimum of 3-5 years of experience 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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