About this role
Quality Consulting Group, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated Senior Process Engineer to join our team. You'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico and USA. This role focuses on technical engineering support in manufacturing.
Provide technical and sustaining engineering support in a manufacturing area on a daily basis. Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, and production yields for existing products. Integrate equipment and material capabilities to meet process module target specifications.
Interact with product design and development personnel to ensure processes and designs are compatible. Review product development requirements for compatibility with processing methods to determine costs and schedules. Join an enthusiastic team in a dynamic pharmaceutical manufacturing environment.
Lead the innovation, development, and optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations. Develop manufacturing processes applicable to statistical process control, including measurement systems. Ensure processes and procedures comply with regulations.
Requirements
- Bachelor's degree in Engineering (Mechanical, Electrical, or Chemical preferred)
- Hands-on experience managing process, performing troubleshooting and implementation of projects
- Specific technical expertise in one or more of the following areas: pneumatics, laser, welding, ultrasonic joining, sensors and control systems, robotics, servo systems, sealing and packaging, vision systems, bonding processes, cleaning processes, and injection molding
- Knowledgeable on basic Process Controls (software, electrical, and mechanical) requirements typical of an automated process, including PLC, HMI, vision systems, and motion controls
- Minimum of 5 years of experience in Validation protocols and reports such as Equipment IQ, Computer System Validations, Process Characterizations, Process OQ/PQ
- Knowledge in Medical Devices regulations
- Onsite, full time
- Availability to work first shift
Responsibilities
- Provide technical and sustaining engineering support in a manufacturing area
- Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, and production yields for existing products
- Integrate equipment and material capabilities to meet process module target specifications and technology target specifications
- Review product development requirements for compatibility with processing methods to determine costs and schedules
- Interact with product design and development personnel to ensure that processes and designs are compatible
- Lead the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations
- Develop manufacturing processes that are applicable to statistical process control and develop those techniques including the measurement systems
- Ensure processes and procedures are in compliance with regulations
Benefits
- Equal opportunity employer
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