Manufacturing Process Investigation Expert

As a Manufacturing Process Investigation Expert, you will be responsible for managing backloggs and deviations occurring in the downstream manufacturing suites.

This role combines technical depth, structured problem-solving, and cross-functional collaboration to drive robust manufacturing performance and maintain GMP compliance.

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Key Responsibilities

• Manage deviations within the downstream manufacturing area in accordance with quality system requirements.

• Perform impact evaluations on equipment, products, and materials in collaboration with subject matter experts.

• Conduct root cause investigations using Six Sigma methodologies and on-the-floor data collection.

• Identify and implement corrective and preventive actions (CAPA), including preparation of business cases and planning with stakeholders.

• Write scientific and comprehensive investigation and impact assessment reports.

• Present investigation outcomes and escalate critical issues to the line manager.

• Monitor and control deviation and CAPA KPIs with the line manager.

• Lead cross-functional investigation teams and facilitate workshops or brainstorming sessions, depending on complexity.

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Essential Requirements

• Bachelor or Master’s degree in Engineering (Chemical, Biotechnology) or equivalent experience.

• 3–5 years of experience in a biotech/pharmaceutical GMP manufacturing environment.

• Strong knowledge of biotechnological processes (DSP) and detailed manufacturing operations.

• Solid understanding of cGMP and regulatory expectations.

• Ability to simplify complex technical problems into clear and concise reports.

• Strong cross-functional collaboration skills, interacting with Manufacturing, MSAT, QA, QC, Engineering, and EHS.

• Fluency in French and excellent command of English.

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Preferred Requirements

• Experience working with automated systems, execution systems, and data management tools.

• Familiarity with Six Sigma investigation methodologies (DMAIC, Ishikawa, 5M, contradiction matrix).

• Strong problem-solving mindset: detail-oriented, structured, pragmatic, and resilient.

• Leadership qualities and strong communication skills (written and oral).

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Practicalities

• Start Date: 01.12.2025 

• Contract Duration: 3 months initially

• Location: Fenil-sur-Corsier, Switzerland

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Interested?

Interviews and offers can move fast. Send your CV to [Name] at [email] or call [phone number] today to secure your spot in the process.