GMP Change Control Lead, Tech Transfer & CAPEX

Katalyst CRO; Vacaville (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst CRO in Vacaville, CA is seeking a Project Administrator to support Technology Transfer and CAPEX projects by managing Change Controls from initiation through closure. You will collaborate with Project Managers and cross-functional teams to ensure changes are executed compliantly, approvals on schedule, and deliverables met in a GMP biopharmaceutical setting.

This role emphasizes timeline management, documentation, and stakeholder communication to drive Change Control execution and

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 2+ years in biotech/pharma or GMP-regulated industries.
• Experience coordinating Change Controls in a complex regulated environment.
• Experience with eQMS platforms (Veeva, TrackWise, MasterControl) preferred.

Responsibilities

• Own and manage Change Controls across Technology Transfer projects.
• Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams.
• Schedule meetings, document minutes, track action items.
• Ensure compliance with cGMP and site procedures; maintain audit-ready records.

Skills

Change Control

Project coordination

GMP

Documentation

Stakeholder management

Education

Bachelor's degree in Life Sciences / Engineering

Tools

Veeva

TrackWise

MasterControl

Job description

Katalyst CRO in Vacaville, CA is seeking a Project Administrator to support Technology Transfer and CAPEX projects by managing Change Controls from initiation through closure. You will collaborate with Project Managers and cross-functional teams to ensure changes are executed compliantly, approvals on schedule, and deliverables met in a GMP biopharmaceutical setting.

This role emphasizes timeline management, documentation, and stakeholder communication to drive Change Control execution and