Qualification/Validation Activities for Equipment, Systems, and Processes
Our client is a leading biopharmaceutical company, renowned for its globally recognized product portfolio. To support a significant ongoing investment project, we are seeking an experienced C&Q Engineer to join their Manufacturing & Technical Services Team.
What You’ll Do:
* Lead and execute qualification/validation activities for equipment, systems, and processes.
* Develop and implement C&Q and CSV strategies based on risk assessment and scientific rationale.
* Ensure compliance with cGMP standards, local policies, and global strategies.
* Collaborate with internal and external teams, including vendors, to maintain operational excellence.
* Serve as a Subject Matter Expert (SME) in audits, change controls, and risk assessments.
This specific assignment shall be started in March and is planned for 8 months with high probability of prolongation till 2026!
Your Profile:
* Experience: 5+ years in pharmaceutical validation.
* Education: BS/MS in Engineering or related technical field.
* Skills: Proficiency in cGxP, 21 CFR Part 11, EU-GMP, GAMP, and data integrity principles.
* Languages: Fluent in English; French is a plus.
* Location: Based in Switzerland or holding a Swiss work permit.
Why Join?
* You’ll be at the forefront of manufacturing excellence and new product introductions in oral solid dosage forms. Join a collaborative environment that fosters innovation and professional growth.
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