Job Description
The candidate will be responsible for ensuring 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 risk. The production engineer will ensure business continuity, enhance process robustness, and oversee the continuous improvement of production operations, particularly in aseptic and terminal sterilized processes, providing both technical expertise and GMP competencies.
This role supports daily production activities and executes improvement projects within the compliance area while translating operational excellence strategic initiatives into actionable tasks. The production engineer will report to the production manager and collaborate 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, leading weekly production planning execution, supporting shop floor daily activities, and when needed, coordinating and supervising production crew setup and allocation.
- 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, acting as the focal point for the continuous improvement process on the shop floor.
- Collaborate with other industrial departments to mitigate unplanned events, developing remediation plans and supporting qualification, validation, and metrology activities with the QA department; work together to improve machinery availability with the Maintenance Department.
- Manage quality events related to production (change control, deviations, CAPA, claims) by leading root cause analysis and investigations using standardized tools; implement effective preventive and corrective actions to reduce 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 finance on production-related costs, manufacturing cost structures, and stock management.
Requirements
- Degree in process engineering, chemical engineering, or related fields.
- A minimum of 5 years of experience in sterile production, with aseptic and terminal sterilized operations being 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 skills.
- Structured, focused, and organized approach to work.
- Fluent in French and English (written and spoken).
What We Offer
We provide permanent, full-time employment in a stimulating and dynamic work environment, fostering a positive culture rich in diversity.
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.