Project Specialist Lonza - 3.4 Vacaville, CA Job Details Full-time 22 hours ago Qualifications Project change management Change management Regulatory/legal compliance standards in production Biomedical regulatory compliance Project stakeholder communication Cross-functional communication Full Job Description Project Administrator Role Summary The Project Administrator supports Technology Transfer and CAPEX projects by managing and coordinating Change Controls from initiation through to final closure. Working closely with Project Managers and cross-functional teams, you will ensure changes are executed compliantly, approvals are secured on schedule, and project deliverables are completed safely, right-first-time, and on time within a cGMP-regulated biopharmaceutical environment. Key Responsibilities 1. Change Control Management & Execution Own and manage Change Controls supporting Technology Transfer and CAPEX projects through their full lifecycle. Drive Change Controls through execution, ensuring timely completion of action items, cross-functional approvals, and implementation activities. Actively monitor project timelines, identify operational bottlenecks or risks, and proactively escalate issues as needed. Partner with Quality Assurance, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain teams to support seamless change implementation. 2. Project Administration & Governance Schedule and facilitate project meetings, capture accurate meeting minutes, and track action items through to completion. Assist Project Managers with baseline project planning, status tracking, risk management, and cross-functional coordination. Maintain complete, accurate, and audit-ready project documentation within approved repository platforms. Prepare routine status reports, milestone updates, and stakeholder communications. 3. Compliance & Quality System Alignment Ensure all Change Controls and project records strictly comply with site Standard Operating Procedures (SOPs) and cGMP regulations. Support site inspection readiness and internal/external regulatory compliance activities. Drive cross-functional accountability to achieve project timelines and key business objectives.

Key Requirements Education & Qualifications Education:

Bachelor's degree in Life Sciences, Biotechnology, Engineering, Quality, Business Administration, or a related discipline preferred (or equivalent practical experience).

Work Experience & Skills Industry Experience:

2+ years of experience in biotechnology, pharmaceutical, medical device, or other cGMP-regulated manufacturing environments.

Quality Systems:

Direct experience managing or coordinating Change Controls within a complex regulated environment. Software /

Platforms:

Experience using electronic Quality Management Systems (eQMS) and Change Control platforms (such as Veeva, TrackWise, MasterControl, or equivalent) is strongly preferred.

Core Competencies:

Strong foundational understanding of Change Control processes and Quality Systems. Familiarity with cGMP guidelines and regulated biomanufacturing environments. Excellent organizational, written/verbal communication, and stakeholder management skills. Ability to prioritize multiple initiatives and drive deliverables across cross-functional teams. Meticulous attention to detail and dedication to maintaining compliant documentation. Preferred Background Quality Assurance (QA) or Compliance / Quality Systems Biotech or Pharmaceutical Manufacturing Engineering or Validation Technology Transfer Support Project Administration or Project Coordination About Lonza Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world—and that's the kind of work we want to be part of every day, Lonza's products and services have a positive impact on millions of people. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world and making a meaningful difference.