GMP Change Control Specialist - Tech Transfer & CAPEX

Katalyst-Healthcares-; Vacaville (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Katalyst-Healthcares- in Vacaville, California, seeks a detail-oriented Project Specialist to support Technology Transfer and CAPEX projects within a GMP-regulated biopharmaceutical environment. You will coordinate Change Controls from initiation through closure, track timelines, secure approvals, and ensure cGMP compliance with site procedures.

The role requires collaboration with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain to drive action items, maintain

Qualifications

• Minimum of 2 years of experience in GMP-regulated industries.
• Bachelor's degree in Life Sciences or related field.
• Experience coordinating Change Controls within regulated manufacturing or quality environments.

Responsibilities

• Coordinate Change Controls from initiation through closure.
• Track actions, approvals, and milestones for CAPEX projects.
• Collaborate with QA, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain.
• Maintain audit-ready documentation per cGMP standards.
• Utilize eQMS platforms (Veeva, TrackWise, MasterControl) to manage changes.
• Provide regular status updates to stakeholders.

Skills

Cross-functional collaboration

Documentation accuracy

Attention to detail

Project coordination

Change Control

GMP compliance

Education

Bachelor's degree in Life Sciences or related

2+ years experience in GMP-regulated industries

Tools

Veeva

TrackWise

MasterControl

Job description

Katalyst-Healthcares- in Vacaville, California, seeks a detail-oriented Project Specialist to support Technology Transfer and CAPEX projects within a GMP-regulated biopharmaceutical environment. You will coordinate Change Controls from initiation through closure, track timelines, secure approvals, and ensure cGMP compliance with site procedures.

The role requires collaboration with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain to drive action items, maintain