Expert Process Manufacturing Support

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

Location: Bulle, Switzerland

Activity rate : 100%

Type of contract: Temporary contract

Start Date: November 2026

Duration of the contract: 12 months

UCB is an international biopharmaceutical company specializing in the therapeutic areas of neurological disorders and immunology. Its Bulle site brings together the Swiss commercial subsidiary and a primary production platform that combines biotechnology and chemistry for the manufacturing and distribution of pharmaceutical specialties used in the treatment of allergies, epilepsy, and autoimmune diseases.

We are looking for a pragmatic, field-oriented Expert Process Manufacturing Support to join our client on a temporary assignment. In this role, you will drive continuous improvement, engineering, and Qualification/Validation (Q/V) initiatives in a cGxP pharmaceutical environment. Operating at the intersection of local site operations and global harmonization, you will step into the field, and collaborate with multi-functional teams.

Your key responsibilities:

• 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 in close collaboration 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 standard operating procedures (SOPs), quality documentation, and training plans.
• Establish, track, and analyze KPIs for Manufacturing Support processes to drive annual maturity and performance targets.
• Engage directly on the shop floor with multi-functional teams to troubleshoot operational issues, coach users, and gather input.

qualifications

What will make you successful:

• Proven experience in continuous improvement within a cGxP pharmaceutical plant, with strong technical knowledge in Engineering, Qualification, and Process Validation.
• Strong knowledge of FDA, EMA and ASTM E2500 requirements.
• Solid hands-on experience applying Lean and Kaizen methodologies to streamline processes and eliminate operational waste.
• Proactive, autonomous, and field-oriented professional who isn't afraid to go onto the shop floor to gather information and solve issues.
• Strong leadership and communication skills, with the ability to tailor your message when interacting with a wide variety of stakeholders.
• Practical expertise in Risk Analysis methodologies, data integrity principles, and drafting GxP quality documentation.
• Demonstrated ability to manage local projects, perform gap assessments, and drive cross-site process harmonization with global and Belgium teams.
• Professional fluency in both French and English (written and spoken) is required.

travailler chez UCB

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