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 essential for maintaining operations in a state of control while systematically reducing waste, variability, and quality risks. The Production Engineer will contribute to business continuity, enhance process robustness, and oversee the continuous improvement of production operations, specifically for aseptic and terminal sterilized processes. This position requires strong technical and GMP competencies.
This role supports daily production activities and executes improvement projects, translating operational excellence strategic initiatives into actionable steps. The Production Engineer will report to the Production Manager and collaborate closely with the QA, Maintenance, and Supply Chain departments.
Main Responsibilities
- Support the Production Manager in daily activities, ensuring business continuity and GMP compliance of production processes by mitigating technical and operational risks.
- Lead weekly production planning execution and support shop floor daily activities; coordinate and supervise production crew setup and allocation as necessary.
- 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 enhance safety, quality, and productivity, acting as the focal point for continuous improvement on the shop floor.
- Collaborate with other industrial departments to mitigate unplanned events and develop remediation plans, including supporting qualification, validation, and metrology activities with the QA department.
- Work with the Maintenance Department to improve machinery availability and manage quality events related to production, including change control, deviations, CAPA, and claims.
- Drive root cause analysis and investigations, adopting standardized tools, and implement effective preventive and corrective actions to reduce recurring deviations.
- Prepare and review production documentation, including batch records and SOPs.
- Initiate and execute efficiency projects 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 finance on production-related cost topics, the manufacturing cost structure, and stock management.
Requirements
- A degree in Process Engineering, Chemical Engineering, or related fields.
- A minimum of 5 years of experience in sterile production, particularly 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).
We offer permanent, full-time employment in a stimulating and dynamic work environment that promotes a positive culture rich in diversity. Sintetica is committed to 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.