LabWare LIMS Computer System Validation Engineer (5)
all cities, CA 5On-sitePosted 22 hours ago
Business Services & Consulting
About the Role
Job Title
Responsibilities
Develop Validation Plans and Change Controls for LabWare LIMS v6 (Laboratory Information Management System)
Develop Validation testing strategy in accordance with the client's policy and procedures
Work 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
Work independently but recognize the need to consult stake holders and keep them informed of progress.
Required Experience / Skills:
Advanced knowledge and expertise Computer System Validation, FDA & international requirements and Part 11 requirements.
Minimum of 3-5 years of experience working on a LabWare LIMS application and GMP pharmaceutical / biotechnology / medical device environment.
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.
Detail oriented script writing abilities
Required Education:
BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.
Job Title
Responsibilities
Develop Validation Plans and Change Controls for LabWare LIMS v6 (Laboratory Information Management System)
Develop Validation testing strategy in accordance with the client's policy and procedures
Work 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
Work independently but recognize the need to consult stake holders and keep them informed of progress.
Required Experience / Skills:
Advanced knowledge and expertise Computer System Validation, FDA & international requirements and Part 11 requirements.
Minimum of 3-5 years of experience working on a LabWare LIMS application and GMP pharmaceutical / biotechnology / medical device environment.
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.
Detail oriented script writing abilities
Required Education:
BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.
What You'll Do
Develop Validation Plans and Change Controls for LabWare LIMS v6 (Laboratory Information Management System)
Develop Validation testing strategy in accordance with the client's policy and procedures
Work 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
