Sr Compliance Engineer
On-siteSchaffhausen, Schaffhausen, Switzerland
Job Summary
Lead Engineering and Qualification for process equipment, utilities, and computerized systems in the Fill & Finish pilot plant. Support validation operations, including scale-up, optimization, and preparation of compliance documents, while troubleshooting failures and managing non-conformance events. Design aseptic process systems, write protocols and reports, and supervise technical order systems. Evaluate analytical results to maintain batch quality and propose technologies that enhance product quality and regulatory compliance. Collaborate with production, suppliers, and global engineering teams to implement change controls and drive efficiency. Requires German and English bilingualism and 4-6 years of pharmaceutical process engineering experience.
Required Qualifications
- Bilingual German & English
- 4-6 years' of experience in the pharmaceutical/food/chemical environment
- Strong knowledge of aseptic fill finish and Annex 1/FDA compliance with all related regulatory & guidelines to translate in a technical solution
- Readiness to lead a project team
- Overall understanding of project budgeting processes and systems
- Understanding of the own role and the role of the department within the broader organization (CSC/DPDS/IMSC)
Desired Qualifications
- Additional experience in the aseptic field
- Agile Decision Making
- Coaching
- Critical Thinking
- Emerging Technologies
- Engineering
- Problem Solving
- Process Control
- Process Engineering
- Process Improvements
- Product Costing
- Product Improvements
- Research and Development
- SAP Product Lifecycle Management
- Situational Awareness
- Technical Research
- Technical Writing
- Technologically Savvy
- Vendor Selection
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