02 oct
|
Anaconda Biomed
|
Cataluña
02 oct
Anaconda Biomed
Cataluña
Process Engineer At Anaconda Biomed, we are seeking a motivated Process Engineer to develop, optimize, validate, and transfer manufacturing processes for innovative medical devices. You will help scale and improve manufacturing processes, support technology transfers from R&D; to Production, lead continuous improvement initiatives, and ensure compliance with quality and regulatory requirements. Experience in a regulated environment is required, with preference for candidates from the Medical Device industry or the pharmaceutical, biotechnology, or healthcare sectors. An advanced level of English is required, both written and spoken. English is regularly used for internal and cross-functional meetings, international collaboration, training, and technical documentation. Key Responsibilities
- Design, develop, optimize, and validate manufacturing processes.
- Support technology transfers from R&D; to Production.
- Analyze process performance and identify improvement opportunities.
- Define, control, and monitor critical process parameters.
- Design and execute process characterization studies and Design of Experiments (DoE).
- Support process validation and equipment qualification.
- Investigate deviations and non-conformities and support corrective and preventive actions.
- Collaborate with Production, Quality, R&D;, Regulatory Affairs, and Supply Chain teams.
- Prepare and maintain technical documentation in line with Quality Management System requirements.
- Support continuous improvement projects using Lean Manufacturing, Kaizen, TPM, and 5S methodologies.
- Define, monitor, and analyze KPIs related to quality, efficiency, and process performance.
- Support the implementation, commissioning, and optimization of new manufacturing equipment and technologies.
- Ensure compliance with internal procedures and applicable regulatory requirements.
Requirements
- Bachelor's degree in Mechanical, Industrial, Biomedical, or Chemical Engineering, or a related field.
- Experience
📌 Process Engineer (Cataluña)
🏢 Anaconda Biomed
📍 Cataluña