Project Specialist

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. #J-18808-Ljbffr