Senior Process Engineer Validation
On-siteBalsthal, Solothurn, Switzerland
Job Summary
Senior Process Engineer Validation at Jabil Switzerland (Hägendorf/Balsthal) responsible for preparing, reviewing, and executing validation documentation (IQ, OQ, PQ) with Quality Assurance and Production to ensure robust, compliant validation activities in accordance with the QMS and regulatory requirements. Evaluates and approves change requests affecting validation, supports equipment lifecycle activities including decommissioning, and performs statistical analyses (e.g., with Minitab). Actively supports NPI projects across the product lifecycle, participates in internal and external audits, contributes to key business metrics through technical support to value-stream processes, leads cost-management projects (scrap, rework, consumables), and promotes a safety culture. Requires a Bachelor's/Master's degree in a relevant field or equivalent experience, 5+ years in medical devices or regulated industries, Lean Six Sigma preferred, strong communication and problem-solving skills, and fluency in German and English. Offer includes professional development, autonomy, and competitive benefits within a global company, with emphasis on compliance and quality standards and opportunities for involvement in audits and process improvements.
Required Qualifications
- Bachelor and/or Master in a relevant engineering or scientific field, or an equivalent combination of education and relevant professional experience.
- Minimum of 5 years of experience in the medical device industry or in a similarly highly regulated industry (e.g., pharmaceuticals, biotechnology).
- Lean Six Sigma certification is preferred.
- Excellent communication and presentation skills, along with strong problem-solving abilities.
- Extensive experience in validation methodologies, as well as solid knowledge of statistical analysis tools and methods for data evaluation and process optimization.
- Fluency in German and English is required.
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