Senior MSAT Process Engineer supporting the introduction of new cell culture processes to large-scale GMP production at a biotechnological production site in Geel.
Responsibilities
Coördineren van de technology transfer van USP-processen naar GMP-productie.
Ondersteunen van productieactiviteiten op schaal voor nieuwe launches.
Opstellen van procesdocumentatie, batch records en samplingplannen.
Uitvoeren van procesanalyses, trendanalyses en monitoring van kritische parameters.
Ondersteunen van procesvalidaties en Process Performance Qualification.
Execution of qualification activities (IQ/OQ/PQ) for manufacturing equipment, processes, and materials within Enterprise Quality – Change Management & Systems.
Responsibilities
Hands‑on execution role supporting equipment and process qualification activities within a manufacturing environment.
Draft, execute, and close out Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for manufacturing equipment and systems.
Generate qualification reports, document results, and ensure full traceability of records in accordance with internal procedures and applicable regulatory requirements.
Coordinate closely on the factory floor with Manufacturing, Engineering, Quality, and Project teams to complete qualification testing around production windows.
Support documentation remediation, record management, and change‑control linkage for qualified equipment.
Serve as a manufacturing process expert identifying, developing, and implementing process improvements to enhance safety, quality, delivery, and cost performance while supporting new program launches and capital projects.
Responsibilities
Exhibit an objective, fair and professional attitude following The MAGNA Employee’s Charter.
Follow Decostar policies and conduct expected of employees.
Ensure compliance with company policies and business objectives in daily supervision of operations.
Exhibit teamwork and leadership skills and participate in team activities.
Demonstrate problem solving skills for continuous improvement.
Lead or participate in diverse projects within the Technical Operations department, focusing on process engineering for polymeric products in a GMP environment.
Responsibilities
Define, specify and procure new production equipment
Set up, execute and report equipment qualification
Introduce new products, materials or components to production
Set up, execute and report process and cleaning validations
Coordinate studies and changes to improve existing installations and processes
Requirements
HBO work and thinking level with a degree in chemical technology, mechanical engineering or another relevant field
The Experienced Operations Process Engineer supports manufacturing execution for the OTTAVA Capital System production line, providing technical support, process ownership, and continuous improvement on the shop floor.
Compensation
The anticipated base pay range for this Bay Area position is:
$94,000.00 - $150,650.00
Responsibilities
Serve as the process owner for assigned system integration, assembly, and test processes
Provide timely technical support for manufacturing interruptions
Ensure manufacturing work instructions, specifications, process records, and traceability controls are accurate
Define tooling, fixture, equipment, and metrology requirements
Lead structured investigations of complex mechanical, electromechanical, software, and system-level manufacturing and test failures
Requirements
Bachelor's degree in Mechanical, Manufacturing, Industrial, Systems, Biomedical, Mechatronics, Electrical, or a related engineering discipline
Nice to have: Experience manufacturing surgical robotics
Nice to have: Medical capital equipment
Nice to have: Robotic systems
Nice to have: Safety-critical electromechanical products
Lead the design, introduction, build follow-up, acceptance, and validation of new equipment and processes, ensuring project quality, cost, and schedule objectives are met.
Responsibilities
Lead the design, introduction, build follow-up, acceptance, and validation of new equipment and processes
Continuously improve existing manufacturing processes through the engineering change process
Manage projects independently in accordance with company project-management procedures
Maintain engineering-controlled documents, including product specifications, PFMEAs, and process and validation documentation
Prepare or support site documentation required for product registration and internal or external audits
Requirements
Bachelor’s degree or above in Industrial Engineering, Polymer Materials, Mechanical Engineering, Automation, or a related engineering discipline
QA Sterility Assurance LeadNewten23 health AG · Visp, Switzerland