Job in 2108 Couvet, CH: Production Engineer
Established in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide, through innovative science and excellence in development, production and marketing. Our people are the biggest asset. That is why we promote creativity in an exciting environment.
Job Overview
The candidate will ensure that manufacturing processes consistently deliver compliant product output in a robust, repeatable, efficient, and safe way—keeping operations in a state of control while systematically reducing waste, variability, and quality risk. The production engineer ensures business continuity, increases process robustness and oversees continuous improvement of production operations (aseptic and terminal sterilized processes), providing technical and GMP competencies. The role will support daily production activities and execute improvement projects in the compliance area and translate operational excellence strategic initiatives into actions. The role will report to the production manager and collaborate with QA, maintenance and supply chain departments.
Responsibilities
* Support the production manager in daily activities, ensuring business continuity and GMP compliance of production processes: mitigate technical and operational risks; lead weekly production planning execution; support shop-floor daily activities; when needed, coordinate and supervise production crew setup and allocation.
* Develop and implement a training plan for production crew to ensure required level of polyvalence.
* Identify and integrate best practices and optimized working methods to increase safety, quality and productivity; be the focal point for the continuous improvement process in shop-floor.
* Collaborate with other industrial departments to mitigate unplanned events and develop remediation plans: support qualification, validation and metrology activities with QA; collaborate to improve machinery availability with Maintenance.
* Manage quality events related to production (change control, deviations, CAPA, claims): lead root cause analysis and investigation adopt standardized tools; implement effective preventive and corrective actions; contribute to reduce recurring deviations.
* Prepare and review production documentation (batch record, SOPs).
* Drive and execute efficiency and initiatives to enhance operational excellence, improve production yield and reduce OPEX under guidance of OPEX lead.
* Support the implementation of CAPEX projects related to production processes and equipment.
* Interface with supply chain for components stock management and production plan optimization.
* Interface with finance on production-related cost topics, on manufacturing cost structure, stock management.
Requirements
* Degree in Process Engineering, Chemical Engineering or related fields.
* 5 years of experience minimum in sterile production, aseptic and terminal sterilized operations will be an asset.
* Demonstrated knowledge in GMP regulations; knowledge of Annex 1 and contamination control will be considered a plus.
* Experience with Lean manufacturing and continuous improvement methodologies.
* Strong problem solving and analytical approach.
* Structured, focused and organized way of working.
* Fluent in French and English (written and spoken).
Benefits
We offer permanent, full-time employment in a stimulating, dynamic work environment where a positive culture rich in diversity prevails.
Sintetica promotes gender equality and encourages the personal development of its employees.
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