Program coordinator Jobs in Vacaville, CA

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Project Coordinator Change Control & Technology Transfer
Location: Vacaville, CA 95688
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite

Summary:

We are seeking a Project Coordinator Change Control & Technology Transfer / Project Administrator to support Technology Transfer and CAPEX projects within a GMP-regulated biopharmaceutical environment. This role is responsible for coordinating and managing Change Controls from initiation through closure, ensuring timely approvals, compliant execution, accurate documentation, and successful implementation of project deliverables. The Project Administrator will work closely with Project Managers and cross-functional teams to drive Change Control execution, monitor timelines, coordinate project activities, support stakeholder communications, and maintain audit-ready records while ensuring compliance with cGMP and site quality procedures.

Responsibilities:

• Manage and coordinate Change Controls supporting Technology Transfer and CAPEX projects.
• Drive Change Controls through the full lifecycle, including initiation, review, approval, implementation, and closure.
• Monitor project and Change Control timelines, identify risks or delays, and escalate issues when necessary.
• Coordinate activities with Quality, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams.
• Schedule and facilitate project meetings, prepare meeting minutes, and track action items to completion.
• Support Project Managers with project planning, status tracking, milestone management, 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, quality systems, 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.
• Support continuous improvement of Change Control and project coordination processes.

Required Skills:

• Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business, or a related discipline preferred.
• Minimum 2 years of experience in biotechnology, pharmaceutical, medical device, or other GMP-regulated industries.
• Experience managing or coordinating Change Controls in a regulated environment.
• Hands-on experience with electronic Quality Management Systems (eQMS) and Change Control platforms such as Veeva, TrackWise, MasterControl, or similar systems preferred.
• Strong understanding of Change Control processes, quality systems, and regulated documentation practices.
• Knowledge of cGMP requirements and regulated manufacturing environments.
• Excellent organizational and time management skills.
• Strong verbal and written communication skills.
• Effective stakeholder management and cross-functional coordination abilities.
• Ability to manage multiple priorities and drive actions to completion in a fast-paced environment.
• Strong attention to detail and documentation accuracy.
• Experience supporting Quality Assurance, Compliance/Quality Systems, Biotech or Pharmaceutical Manufacturing, Engineering, Validation, Technology Transfer, Project Administration, or Project Coordination activities preferred.
• Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook.
• Ability to maintain confidential and compliant project records and support audit and inspection readiness activities.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.