Senior MES Project Leader – Pharma Compliance & Integrations

SII Group; Genf, Zürich; Remote; CHF 180,000 - 240,000; Full time

Job summary

SII Switzerland seeks an experienced MES Project Manager to lead end-to-end MES programs in a highly regulated manufacturing environment. You will drive delivery within scope, budget and timelines while ensuring GMP/GxP, CSV, and 21 CFR Part 11 compliance across cross-functional teams.

Join our Geneva, Lausanne and Zurich offices to collaborate with Manufacturing, Quality, Engineering, IT and Supply Chain, guiding complex integrations with SAP, LIMS and Maximo and mentoring a local MES team on

Qualifications

• Approximately 15 years of project/program management experience, including complex cross-functional projects.
• Approximately 10 years of MES experience in pharmaceutical, biotechnology, or highly regulated manufacturing environments.
• Strong expertise in MES implementations, electronic batch records, recipe management, system integrations, and validation.
• Hands-on experience with Emerson Syncade strongly preferred.
• Solid knowledge of GMP, GxP, GAMP, CSV, SDLC, and 21 CFR Part 11.
• Proven leadership skills, with experience coordinating technical teams and managing multiple stakeholders.
• PMP, PRINCE2, Agile/Scrum, or equivalent certification is an advantage.

Responsibilities

• Lead end-to-end MES projects, ensuring delivery within scope, budget, timelines, and regulatory requirements.
• Manage project planning, resources, risks, budgets, governance, and stakeholder communication.
• Coordinate MES implementations, upgrades, integrations, testing, validation, and deployment.
• Collaborate with Manufacturing, Quality, Engineering, Supply Chain, and IT teams to define requirements and deliver compliant solutions.
• Oversee MES integrations with SAP, LIMS, Maximo, and other manufacturing systems.
• Coordinate the local MES team on an interim basis, including system administrators, recipe authors, engineers, and external contractors.
• Ensure compliance with GMP, GxP, GAMP, CSV, and 21 CFR Part 11 requirements.
• Support operational continuity, incident resolution, process improvements, and change management.

Skills

Project management

Cross-functional leadership

Regulatory compliance

GxP/CSV

Quality systems

MES

Education

Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related field

Tools

Emerson Syncade

SAP

LIMS

Maximo

Job description

SII Switzerland seeks an experienced MES Project Manager to lead end-to-end MES programs in a highly regulated manufacturing environment. You will drive delivery within scope, budget and timelines while ensuring GMP/GxP, CSV, and 21 CFR Part 11 compliance across cross-functional teams.

Join our Geneva, Lausanne and Zurich offices to collaborate with Manufacturing, Quality, Engineering, IT and Supply Chain, guiding complex integrations with SAP, LIMS and Maximo and mentoring a local MES team on