GMP Validation Project Lead - LIMS & Engagement

JC Automation Corp.

Rancho Cordova (CA)

On-site

USD 96,000 - 165,000

Full time

4 days ago
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Job summary

JC Automation Corp. is seeking an Validation Project and Engagement Manager contractor to lead the delivery of validation, qualification, and procedural documentation services for LabWare LIMS expansion in GMP quality control operations.

You will own scope, schedule, cost, and resources, ensuring inspection-ready results for the client. The role requires coordinating distributed teams, managing budgets, and maintaining client relationships.

Qualifications

  • Solid knowledge of project management principles for regulated validation projects.
  • Experience with validation lifecycles (GAMP 5, 21 CFR Part 11) and data integrity.
  • Ability to manage Time and Materials and Fixed Price budgets with forecasting.

Responsibilities

  • Serve as the single accountable engagement lead with client PM and System Owner.
  • Develop engagement plan, WBS, and resource plan across lifecycle stages.
  • Provide input on sequencing, durations, and resource needs for schedule baselining.
  • Allocate resources across phases and coordinate onsite travel for Rancho Cordova.
  • Track progress, deliverables, and hours; report risks to client and JCA.
  • Manage scope changes and change requests; ensure quality reviews before submission.

Skills

Project management
Stakeholder management
Schedule governance
Risk management
Resource coordination
Communication

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science, Information Systems, Business Administration, or related field

Tools

Microsoft Project
Smartsheet
Microsoft Office

Job description

JC Automation Corp. is seeking an Validation Project and Engagement Manager contractor to lead the delivery of validation, qualification, and procedural documentation services for LabWare LIMS expansion in GMP quality control operations.

You will own scope, schedule, cost, and resources, ensuring inspection-ready results for the client. The role requires coordinating distributed teams, managing budgets, and maintaining client relationships.

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