Technology Transfer & Change Control Specialist

Creative Solutions Services, LLC; Vacaville (CA); On-site; USD 43,000 - 70,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Project Specialist to support Technology Transfer and CAPEX projects by managing and coordinating Change Controls from initiation through closure.

This role works closely with Project Managers and cross-functional teams to ensure changes are executed compliantly, approvals are obtained on schedule, and project deliverables are completed on time in a GMP-regulated biopharmaceutical environment.

Qualifications

• 2+ years of experience in biotechnology, pharmaceutical, medical device, or other GMP-regulated industries.
• Experience managing or coordinating Change Controls in a complex regulated environment.
• Experience with electronic Quality Management Systems (eQMS) and Change Control platforms such as Veeva, TrackWise, MasterControl, or similar systems is strongly preferred.

Responsibilities

• Own and manage Change Controls supporting Technology Transfer projects.
• Drive Change Controls through the full lifecycle, ensuring timely completion of actions, approvals, and implementation activities.
• Monitor timelines, identify risks or delays, and elevate issues as needed.
• Coordinate with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams to support successful change implementation.
• Schedule and facilitate project meetings, document meeting minutes, and track action items to completion.
• Support Project Managers with project planning, status tracking, and cross-functional coordination.
• Maintain project documentation and provide regular updates on project and Change Control status.
• Assist with project reporting, milestone tracking, and stakeholder communications.
• Ensure Change Controls and project documentation comply with site procedures and cGMP requirements.
• Maintain accurate, complete, and audit-ready records.
• Support inspection readiness and regulatory compliance activities.
• Drive accountability across stakeholder groups to meet project timelines and business objectives.

Skills

Change Control

GMP knowledge

Cross-functional coordination

Project administration

Documentation

Education

Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or related

Tools

Veeva

TrackWise

MasterControl

Job description

Creative Solutions Services, LLC is seeking a Project Specialist to support Technology Transfer and CAPEX projects by managing and coordinating Change Controls from initiation through closure.

This role works closely with Project Managers and cross-functional teams to ensure changes are executed compliantly, approvals are obtained on schedule, and project deliverables are completed on time in a GMP-regulated biopharmaceutical environment.