Title: Lead LabWare LIMS Computer System Validation Specialist 
 
Type of role: Contract 12-24++ months 
Location: Foster City, CA 
 
Primary Responsibilities:

<ul>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Lead validation activities directly associated with clients LabWare LIMS. 

<ul>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">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.</li>
</ul>
</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Provide strong validation direction to internal and external project team members.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">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.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Oversee team contributions to deliverables, testing activities and ensure validation testing is conducted in an appropriate and timely manner.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Work collaboratively across functions with Quality Management, IT, Business, Vendors and Consultants to plan, coordinate and execute computer system validation activities.</li>
</ul>
 
Knowledge and Skill Requirements:

<ul>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Minimum 8 years of validation experience.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">4 + years experienced in validating LabWare LIMS</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Strong experience in leading and performing validation activities.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Ability to manage internal and external resources to deliver required validation package and execution.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Excellent problem solving skills</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Ability to work independently as a Senior Validation, provide guidance to project team on validation approach and communicate risks or issues to management.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Strong foundational understanding and experience leading validation workstream.</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Strong knowledge of 21 CFR Part 11, Annex 11 and cGMPS</li>
<li style="padding: 0; margin: 0;" style="padding: 0; margin: 0;">Excellent verbal and written skills</li>
</ul>

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Lead Labware Lims Computer System Validation Specialist

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