Lonza MSP US
Project Specialist
Project Administrator
Join our dynamic team supporting Technology Transfer and CAPEX projects by managing and coordinating Change Controls from initiation to closure, ensuring compliant and timely execution within a cGMP biopharmaceutical environment.
This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards and the contract duration is 6 months.
What you will get:An agile career and dynamic working culture.
An inclusive and ethical workplace.
Competitive hourly rate.
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
What you will do:
Own and manage the end-to-end lifecycle of Change Controls for Technology Transfer and CAPEX projects, ensuring safety, compliance, and right-first-time execution.
Partner closely with cross-functional stakeholders in Quality Assurance, Manufacturing, Engineering, Validation, Regulatory, and Supply Chain to drive seamless change implementation.
Drive Change Control execution by proactively identifying operational bottlenecks, managing risks, and ensuring timely completion of action items and approvals.
Schedule and facilitate project meetings, document accurate meeting minutes, and track critical action items to maintain project governance.
Assist Project Managers with baseline project planning, status tracking, milestone updates, and routine stakeholder reporting.
Maintain complete, accurate, and audit-ready project documentation within approved repository platforms in alignment with site SOPs and cGMP regulations.
Support site inspection readiness and internal/external regulatory compliance activities to deliver key business objectives.
What we are looking for:
Industry Experience: 2+ years of experience in biotechnology, pharmaceutical, medical device, or another cGMP-regulated manufacturing environment.
Quality Systems: Direct experience managing or coordinating Change Control workflows within an electronic Quality Management System (eQMS) such as Veeva, TrackWise, or MasterControl.
Functional Knowledge: Strong foundational understanding of Change Control processes, site SOPs, and cGMP guidelines supporting tech transfer and CAPEX projects.
Stakeholder Management: Proven capability to collaborate, communicate effectively, and build strong relationships across cross-functional teams.
Organization & Detail: Exceptional organizational skills with meticulous attention to detail in creating and maintaining compliant, audit-ready documentation.
Problem-Solving & Prioritization: Ability to prioritize multiple project initiatives, resolve operational risks, and drive deliverables on schedule.
Education & Transferable Skills: Bachelor’s degree in Life Sciences, Biotechnology, Engineering, Quality, Business Administration, or a related discipline (or equivalent practical, hands-on industry experience).
About Lonza
At Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work they want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment.
As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.
Ready to play your part in shaping the future of life sciences? Apply now.