Manufacturing Engineer

Rani Therapeutics; Fremont (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company in California is looking for a Manufacturing Engineer to support the manufacturing of innovative drug delivery systems. You will play a critical role in troubleshooting production issues, ensuring compliance with standards, and fostering continuous improvement in operations. Candidates should have 3–7 years of experience in a manufacturing environment, strong analytical skills, and a Bachelor's Degree in a relevant engineering field. Familiarity with FDA regulations and statistical analysis tools is preferred.

Qualifications

• 3–7 years of hands-on experience in a manufacturing environment.
• Extensive experience with process capability studies and FMEA.
• Knowledge of material science and polymer chemistry.

Responsibilities

• Support NPI and troubleshoot issues on the production floor.
• Collaborate with Development and R&D Engineers for effective design transfer.
• Conduct process capability studies and apply statistical methods.

Skills

Process development

Statistical data analysis

Problem-solving

Collaboration

Root cause analysis

Education

Bachelor’s Degree in Mechanical, Chemical, Manufacturing or related field

Tools

SolidWorks

Statistical Software tools like Minitab or JMP

Job description

Overview

MANUFACTURING ENGINEER

The Manufacturing Engineer plays a critical role in supporting the manufacturing of Rani Capsules. This role involves providing technical assistance in the installation, preventative maintenance, and calibration of equipment, as well as ensuring process improvements and consistency in manufacturing operations. The position works closely with R&D engineering and quality teams to ensure device specifications align with device requirements.

Responsibilities

• Actively support NPI by working hands-on on the production floor to troubleshoot issues, stabilize yields, and drive smooth transitions from development to full-scale manufacturing.
• Collaborate with Development and R&D Engineers to execute effective design transfer, process characterization, and ramp plans.
• Conduct process capability studies and apply DOE, SPC, and data-driven analysis to draw conclusions, implement improvements, and sustain gains.
• Develop standard work, process controls, and monitoring methods to reduce variability across operators, materials, equipment, and workflows.
• Investigate process deviations and failures; perform structured root cause analysis (5-Why, Fishbone, FMEA) and implement robust corrective and preventive actions (CAPA).
• Proactively identify opportunities for improvement and challenge assumptions constructively to drive better outcomes.
• Create and execute IQ/OQ/PQ and related verification and validation protocols, analyze results, and generate complete documentation and reports.
• Ensure compliance with design control, validation, documentation, and change-control policies (FDA, ISO, cGMP, QMS).
• Create and maintain clear, complete manufacturing documentation (MPIs, LHRs, WIs, forms, checklists) that reflect current practices and controls.
• Train and guide technicians and assemblers; drive best practices and foster a culture of safety, quality, and continuous improvement.
• Contribute to design-for-manufacturability (DFM), cost reduction, quality improvement, and automation initiatives.
• Cultivate a mindset of ownership and innovation, where individuals actively seek out challenges and collaborate across teams to solve them.

Experience

• 3–7 years of hands-on experience in a manufacturing environment, with a proven track record in process development, optimization, and validation.
• Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC, and process development/validation.
• Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes.
• Proven ability to perform statistical data analysis and implement improvement plans using DOE and other methods.
• Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis.
• Knowledge of material science and polymer chemistry.
• Diverse background in process characterization and optimization in a manufacturing environment.
• Experience with FDA regulations and ISO, cGMP, and QMS standards.
• Experience with Statistical Software tools such as Minitab or JMP.
• Familiarity with cleaning and sterilization processes.
• Working knowledge of SolidWorks.

Education

• Bachelor’s Degree in Mechanical, Chemical, Manufacturing, or a related engineering field.
• Relevant certifications as pertains to the position (e.g., Six Sigma, Lean Manufacturing, etc.) is a plus.
• Proficiency in Microsoft Excel, Microsoft Word, and other engineering software tools.
• Familiarity with metrology tools such as CMM, Micro-Vu, SEM, etc. is a plus.

Physical Demands

• The employee is regularly required to stand, walk, and sit for extended periods during the performance of job duties.
• Must be able to physically be present on-site to perform the required tasks.