Project Specialist

swipejobs; Vacaville (CA); On-site; USD 446,400 - 781,200; Full time

Job summary

SwipeJobs is seeking a Project Specialist to support Technology Transfer and CAPEX projects in a GMP biopharmaceutical environment.

You will coordinate Change Controls, track activities, attend cross-functional meetings with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain, and help keep records audit-ready.

This 6-month contract offers hands-on exposure to cGMP compliance and regulatory standards, with collaboration across teams to ensure on-time project delivery.

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Engineering, Quality, or related discipline.
• 2+ years in biotechnology, pharmaceutical, medical device, or GMP-regulated environments.
• Experience coordinating Change Controls or quality system processes.

Responsibilities

• Coordinate project activities and deliverables for Technology Transfer and CAPEX projects.
• Manage and track Change Controls from initiation through completion with required actions and approvals.
• Monitor timelines, identify risks, and communicate updates to project teams.

Skills

Project coordination

Change Controls

Cross-functional collaboration

Documentation management

Audits readiness

Scheduling

Education

Bachelor’s degree in Life Sciences/Engineering/Quality or related field

Tools

Veeva

TrackWise

MasterControl

Job description

Duration: 6-month contract with potential extension

We are seeking a Project Specialist to support Technology Transfer and CAPEX projects within a GMP-regulated biopharmaceutical environment. This role will provide project coordination support by managing Change Controls, tracking project activities, and partnering with cross-functional teams to ensure successful project execution and compliance.

Key Responsibilities

• Support Technology Transfer and CAPEX projects by coordinating project activities and deliverables.
• Manage and track Change Controls from initiation through completion, ensuring required actions, approvals, and implementation activities are completed on schedule.
• Monitor project timelines, identify potential risks or delays, and communicate updates to project teams.
• Coordinate with cross-functional groups including Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain.
• Schedule project meetings, capture meeting minutes, and track action items through completion.
• Assist Project Managers with project planning, status updates, milestone tracking, and stakeholder communication.
• Maintain accurate project documentation and ensure records are complete and audit-ready.
• Support cGMP compliance, inspection readiness, and regulatory requirements.

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or a related discipline preferred.
• 2+ years of experience in biotechnology, pharmaceutical, medical device, or other GMP-regulated environments.
• Experience supporting project coordination, Change Controls, or quality system processes.
• Familiarity with cGMP requirements and regulated manufacturing environments.
• Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, MasterControl, or similar platforms preferred.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent communication skills with the ability to collaborate across cross-functional teams.
• Strong attention to detail and documentation management skills.