PSC Biotech needs to ensure that healthcare products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. This role will support pharmaceutical manufacturing programs by designing, developing, integrating, and validating robotic systems.
Requirements
- Proficiency with CAD tools (SolidWorks, Creo, or similar) and experience with motion control, actuators, and sensor integration.
- Familiarity with programming languages used in robotics (Python, C++, MATLAB, ROS, PLC logic, etc.).
- Experience contributing to structured validation or testing activities (e.g., system verification, protocol execution, structured acceptance testing).
- Strong understanding of risk analysis, system safety, and reliability engineering.
- 7+ years experience designing, integrating, or validating robotic or electromechanical systems—preferably in a regulated environment (pharma, medical device, biotech, or advanced manufacturing).
- Ensure all robotic systems comply with FDA, EU, and global GxP expectations related to data integrity, safety, and product quality.
Responsibilities
- Design, model, and prototype robotic mechanisms, actuators, and motion systems appropriate for aseptic and controlled environments.
- Develop control algorithms, sensor integrations, and automation logic for precise robotic manipulation and handling tasks.
- Lead system integration activities, ensuring seamless coordination between mechanical, electrical, software, and control system components.
- Perform risk assessments (FMEA, hazard analyses) aligned with pharmaceutical quality and safety expectations.
- Support commissioning, qualification, and validation (IQ/OQ/PQ‑aligned testing methodology) of robotic systems in accordance with internal quality systems and regulatory guidelines.
- Develop engineering documentation, including CAD models, technical specifications, test protocols, validation deliverables, and traceability records.
- Collaborate with Quality, Manufacturing, R&D, and Automation teams to troubleshoot issues, optimize performance, and maintain ongoing system reliability.
Other
- Bachelor's degree in Robotics Engineering, Mechanical Engineering, Mechatronics, Electrical Engineering, or related discipline (advanced degree preferred).
- Excellent communication skills and the ability to work cross‑functionally in multidisciplinary engineering teams.
- Must be authorized to work in the U.S.
- No C2C at this time.
- The salary bracket for this role is set between $130,000 - $150,000 annually.
