Job Opportunity: Production Engineer
The candidate will be responsible for ensuring that manufacturing processes consistently deliver compliant product output in a robust, repeatable, efficient, and safe manner. The objective is to keep operations controlled while systematically reducing waste, variability, and quality risks. The Production Engineer plays a crucial role in ensuring business continuity, enhancing process robustness, and overseeing continuous improvements in production operations, including aseptic and terminal sterilized processes. This position provides technical and GMP competencies and requires collaboration with various departments.
Main Responsibilities
- Support the Production Manager in daily activities, ensuring business continuity and GMP compliance of production processes. This includes mitigating technical and operational risks, leading weekly production planning execution, and coordinating production crew setup and allocation as needed.
- Develop and implement a training plan for the production crew to ensure the required level of polyvalence.
- Identify and integrate best practices and optimized working methods to increase safety, quality, and productivity, serving as the focal point for the continuous improvement process on the shop floor.
- Collaborate with other industrial departments to mitigate unplanned events and develop remediation plans. This involves supporting qualification, validation, and metrology activities with the QA department, as well as enhancing machinery availability with the Maintenance Department.
- Manage quality events related to production, including change control, deviations, CAPA, and claims. Lead root cause analysis and investigation, adopt standardized tools, implement effective preventive and corrective actions, and contribute to reducing recurring deviations.
- Prepare and review production documentation, including batch records and SOPs.
- Drive and execute efficiency initiatives to enhance operational excellence, improve production yield, and reduce OPEX under the guidance of the OPEX lead.
- Support the implementation of CAPEX projects related to production processes and equipment.
- Interface with the supply chain for components stock management and production plan optimization.
- Collaborate with the finance department regarding production-related cost topics, manufacturing cost structure, and stock management.
Requirements
- Degree in Process Engineering, Chemical Engineering, or related fields.
- Minimum of 5 years of experience in sterile production with aseptic and terminal sterilized operations.
- Demonstrated knowledge of GMP regulations; familiarity with Annex 1 and contamination control will be considered a plus.
- Experience with Lean manufacturing and continuous improvement methodologies.
- Strong problem-solving and analytical skills.
- Structured, focused, and organized work approach.
- 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.
Apply online using the form below. Only applications matching the job profile will be considered.