Manufacturing Process Investigation Expert
Direct message the job poster from Panda International
About the Role
As a Manufacturing Process Investigation Expert, you will be responsible for managing backlogs 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.
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 elevate 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.
Required Qualifications
* 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.
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).
Practicalities
* Start Date: 01.12.2025
* Contract Duration: 3 months initially
How to Apply
Interested? Interviews and offers move fast. Send your CV to Merel van Os at m.vanos@panda-int.com or call +41 44 551 44 07 today to secure your spot in the process.
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