Job Description
The candidate will ensure that manufacturing processes consistently deliver compliant product output in a robust, repeatable, efficient, and safe manner. This role is critical for maintaining operational control while systematically reducing waste, variability, and quality risks. The production engineer will ensure business continuity, enhance process robustness, and oversee continuous improvement within production operations (aseptic and terminal sterilized processes) by providing technical expertise and knowledge of Good Manufacturing Practices (GMP).
Reporting to the Production Manager, the production engineer will collaborate closely with the QA, maintenance, and supply chain departments, supporting daily production activities and executing improvement projects.
Main Responsibilities
- Support the Production Manager in daily activities, focusing on business continuity and GMP compliance: mitigate technical and operational risks, lead weekly production planning execution, and support shop floor operations. Coordinate and supervise production crew setup and allocation as needed.
- Develop and implement a training plan for the production crew to ensure the necessary level of versatility.
- Identify and integrate best practices and optimized working methods to enhance safety, quality, and productivity; serve 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: support qualification, validation, and metrology activities with the QA department, and work with the Maintenance Department to improve machinery availability.
- Manage quality events related to production (change control, deviations, CAPA, claims): lead root cause analyses and investigations using standardized tools, and implement effective preventive and corrective actions to reduce recurring deviations.
- Prepare and review production documentation (batch record, SOPs).
- Drive and execute initiatives aimed at enhancing operational excellence, improving production yield, and reducing operational expenditures (OPEX) under the guidance of the OPEX lead.
- Support the implementation of capital expenditure (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, manufacturing cost structure, and stock management.
Requirements
- Bachelor's 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.
- 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.
- A structured, focused, and organized approach to work.
- Fluency in both French and English (written and spoken).
What We Offer
We provide permanent, full-time employment in a stimulating, dynamic work environment characterized by a positive culture rich in diversity. Sintetica promotes gender equality and encourages the personal development of its employees.
Application Process
Apply online using the form below. Only applications matching the job profile will be considered.