Job Description
The candidate will be responsible for ensuring that manufacturing processes consistently produce compliant product outputs in a robust, repeatable, efficient, and safe manner. This role involves maintaining operations in a controlled state while systematically reducing waste, variability, and quality risks. The production engineer plays a vital role in ensuring business continuity, enhancing process robustness, and overseeing the continuous improvement of production operations, specifically in aseptic and terminal sterilization processes. This position provides essential technical and Good Manufacturing Practice (GMP) competencies.
The production engineer will support daily production activities while executing improvement projects in compliance areas and translating operational excellence strategic initiatives into actionable steps. The role reports directly to the production manager and requires collaboration with the QA, maintenance, and supply chain departments.
Main Responsibilities
- Assist the production manager in daily activities, ensuring business continuity and GMP compliance of production processes by mitigating technical and operational risks, leading weekly production planning execution, and supporting shopfloor activities.
- Coordinate and supervise the setup and allocation of production crew as needed.
- Develop and implement a training plan for the production crew to ensure the required level of versatility.
- Identify and integrate best practices and optimized working methods to enhance safety, quality, and productivity, serving as the focal point for continuous improvement processes on the shopfloor.
- Collaborate with other industrial departments to minimize unplanned events and develop remediation plans, supporting qualification, validation, and metrology activities with the QA department and working with the Maintenance Department to improve machinery availability.
- Manage quality events related to production, including change control, deviations, CAPA, and claims. Lead root cause analysis and investigations using standardized tools, implement effective preventive and corrective actions, and contribute to reducing recurring deviations.
- Prepare and review production documentation, including batch records and Standard Operating Procedures (SOPs).
- Drive and execute efficiency initiatives to enhance operational excellence, improve production yield, and reduce operational expenses 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 finance on production-related cost topics, including manufacturing cost structure and stock management.
Requirements
- Degree in process engineering, chemical engineering, or related fields.
- A minimum of 5 years of experience in sterile production, specifically in aseptic and terminal sterilized operations, is an asset.
- Demonstrated knowledge of GMP regulations; familiarity with Annex 1 and contamination control is a plus.
- Experience with Lean manufacturing and continuous improvement methodologies.
- Strong problem-solving and analytical skills.
- Structured, focused, and organized approach to work.
- Fluency in French and English (both written and spoken).
We offer permanent, full-time employment in a stimulating and dynamic work environment characterized by a positive and diverse culture. 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.