The Process Engineer is responsible for designing, implementing, and optimizing manufacturing
processes to improve efficiency, quality, and cost-effectiveness. This role involves analyzing production
systems, troubleshooting process issues, and collaborating with cross-functional teams to support
continuous improvement initiatives.
Key Responsibilities:
• Develop, implement, and optimize manufacturing and production processes.
• Provide Solidworks designs for products/injector systems for clinical and commercial use.
• Support root-cause analysis for process deviations and equipment issues.
• Define process parameters, standard operating conditions, and control strategies.
• Collaborate with R&D, Quality, and Operations teams on product scale-up and transfer.
• Manage trials, validations, and process documentation (P&IDs, SOPs, FMEAs).
• Ensure compliance with safety, environmental, and regulatory standards.
• Provide technical training and support to operations staff.
Qualifications:
• Education: Bachelor’s degree in mechanical engineering, Industrial Engineering, or related field.
• Experience: 0-2+ years of experience in process design, manufacturing, or industrial operations.
• Possess a working knowledge of cGMPs.
Skills:
o Strong analytical and problem-solving abilities
o Proficiency with process simulation and CAD tools (e.g., Solidworks, AutoCAD)
o Knowledge of Lean/Six Sigma methodologies
o Excellent communication and project management skills
Never miss an opportunity! Create an alert based on the job you applied for.
