Job Description
The candidate will ensure that manufacturing processes consistently deliver compliant product output in a robust, repeatable, efficient, and safe manner. This role involves maintaining operations in a state of 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, specifically focusing on aseptic and terminal sterilized processes by providing technical and GMP competencies.
This position supports daily production activities and executes improvement projects within compliance areas, translating operational excellence strategic initiatives into actionable measures. The role reports directly to the production manager and collaborates 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. This includes mitigating technical and operational risks, leading weekly production planning execution, and supporting shop floor daily activities. Coordinate and supervise 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 enhance safety, quality, and productivity; act 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 while working to improve machinery availability with the maintenance department.
- 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 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 supply chain for components stock management and production plan optimization.
- Interface with finance 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; experience in aseptic and terminal sterilized operations is an asset.
- 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 abilities.
- Structured, focused, and organized approach to work.
- Fluency in both French and English (written and spoken).
Employment Offer
We offer permanent, full-time employment in a stimulating and dynamic work environment, where a positive culture rich in diversity prevails. Sintetica promotes gender equality and encourages the personal development of our employees.
Apply online using the form below. Only applications matching the job profile will be considered.