Field Process Manufacturing Expert: Lean & Validation (cGxP)

Randstad (Schweiz) AG; Bulle; Vor Ort; CHF 110.000 - 150.000; Teilzeit

Zusammenfassung

UCB is seeking a pragmatic, field-oriented Expert Process Manufacturing Support for a temporary assignment at the Bulle site. You will drive continuous improvement, engineering, and Q/V initiatives in a cGxP environment, collaborating with local and global teams on site.

You will draft SOPs, update quality documentation, and track KPIs while ensuring compliance with FDA/EMA requirements and data integrity. Start date is November 2026 for 12 months on a 100% activity rate.

Qualifikationen

• Proven experience in continuous improvement within a cGxP pharmaceutical plant.
• Strong knowledge of FDA, EMA and ASTM E2500 requirements.
• Lean and Kaizen methodologies to streamline processes and reduce waste.
• Fluent in both French and English (written and spoken).

Aufgaben

• Drive continuous improvement (Lean/Kaizen) to optimize processes, simplify workflows, and eliminate operational waste.
• Support Engineering, Qualification, and Process Validation (Q/V) activities in full compliance with cGxP regulations.
• Lead cross-site process and tool harmonization initiatives with global teams and Belgium counterparts.
• Perform gap assessments against global standards and evolving pharmaceutical regulations, notably for commissioning activities.
• Support quality digitalization and data integrity initiatives across site documentation and systems.
• Draft, revise, and update SOPs, quality documentation, and training plans.
• Establish, track, and analyze KPIs for Manufacturing Support processes to drive maturity and performance targets.
• Engage on the shop floor with multi-functional teams to troubleshoot operational issues, coach users, and gather input.

Kenntnisse

Lean/Kaizen

Cross-functional leadership

GxP compliance

Process validation

On-site troubleshooting

Data integrity

Quality documentation

French & English

Jobbeschreibung

UCB is seeking a pragmatic, field-oriented Expert Process Manufacturing Support for a temporary assignment at the Bulle site. You will drive continuous improvement, engineering, and Q/V initiatives in a cGxP environment, collaborating with local and global teams on site.

You will draft SOPs, update quality documentation, and track KPIs while ensuring compliance with FDA/EMA requirements and data integrity. Start date is November 2026 for 12 months on a 100% activity rate.