Lead LabWare LIMS Computer System Validation Specialist
Foster City, CA · Biotech/Pharmaceutical
Title: Lead LabWare LIMS Computer System Validation Specialist
Type of role: Contract 12-24++ months Location: Foster City, CA
Lead validation activities directly associated with client’s LabWare LIMS.
This includes: understanding the business, determining business and system requirements, project planning for validation work-stream, and collaborating with project team members in the development and delivery of validation deliverables.
Provide strong validation direction to internal and external project team members.
Author validation deliverables including Validation Plan, User Requirements Specification, Configuration Specification, Design Specification, IQ, Requirements Test Plan and Scripts, Traceability Matrix and Validation Summary Report for assigned projects.
Oversee team contributions to deliverables, testing activities and ensure validation testing is conducted in an appropriate and timely manner.
Work collaboratively across functions with Quality Management, IT, Business, Vendors and Consultants to plan, coordinate and execute computer system validation activities.
Knowledge and Skill Requirements:
Minimum 8 years of validation experience.
4 + years experienced in validating LabWare LIMS
Strong experience in leading and performing validation activities.
Ability to manage internal and external resources to deliver required validation package and execution.
Excellent problem solving skills
Ability to work independently as a Senior Validation, provide guidance to project team on validation approach and communicate risks or issues to management.
Strong foundational understanding and experience leading validation workstream.
Strong knowledge of 21 CFR Part 11, Annex 11 and cGMPS