Sr. Automation Engineer in England

There has never been a more exciting time at Rani Therapeutics. We have successfully tested the RaniPill in humans, and we are working towards the ultimate goal of making the oral delivery of biologics a reality for millions of patients. We are growing rapidly and we are actively hiring.

We are seeking a Sr. Mechanical Automation Engineer to design, develop, and validate semi or fully automated equipment that is used for the scale-up of high volume, platform delivery devices. The Senior Automation Engineer is responsible for designing, implementing, and sustaining high-reliability automated systems for drug–device combination product manufacturing. The role owns line-level automation performance, from PLC/motion and vision through high-volume scale-up, and partners closely with Mechanical Design, Tech Transfer, and Validation to deliver robust, compliant commercial operations. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.

Major Duties and Responsibilities:

• Develop and improve tooling, including semi-automation.
• Demonstrated experience with high-speed automated lines in medical device, biotech, or pharmaceutical manufacturing.
• Assess and enhance manufacturing processes by applying engineering concepts and operator feedback.
• Lead design ownership, URS creation, concept reviews, proof of concept, stakeholder coordination, verification/validation, launch, and documentation.
• Practical experience specifying and commissioning machine vision for precision parts inspection (e.g., Cognex, Keyence).
• Draft detailed work instructions and SOPs.
• Support or lead engineering runs and scale-up from pilot to commercial automation.
• Convert development parameters and URS into automated control recipes.
• Participate in dFMEA/pFMEA, define CPPs/CQAs, and propose control strategies and alarm limits.
• Create and execute verification/validation protocols (IQ/OQ/PQ), collect data, and complete documentation.
• Expertise in PLC/motion programming (e.g., Rockwell/Siemens), structured text, ladder logic, and modular code.
• Experience with servo drives, electronic gearing, camming, and PID tuning.
• Knowledge of PackML/state-based control and ISA 101 HMI design.
• Manage relationships and work with vendors, machine shops, and contract manufacturers.
• Adhere to company policies for design control, validation, and documentation.

Leadership:

• Facilitate regular meetings and communication channels to promote collaboration and alignment across teams.
• Coordinate with cross-functional teams including engineers, consultants, and external partners to ensure project objectives are met on time and within budget.
• Develop team members by providing necessary guidance, identifying necessary training, and providing professional development activities to build competence and depth.
• Develop detailed project plans outlining timelines, milestones, resource requirements, and deliverables while maintaining good design control practices.

Education and/or Job Experience:

• Bachelor's Degree in Mechanical Engineering.
• 5 - 10 years hands-on, relevant experience.
• In-depth experience with complex mechanical/electromechanical design.
• Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
• Experience with creating engineering drawings, BOMs and product specifications.
• Deep knowledge of material properties, heat treatment, and surface finish.
• Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standards.
• Integration with SCADA/MES and basic industrial networking (Ethernet/IP or PROFINET), including good practices for segmentation and security in a GMP setting.
• Good understanding of DFM and lean manufacturing.
• Excellent verbal, written, presentation and interpersonal skills.
• Strong analytical and problem-solving skills.
• Knowledge and/or hands-on experience with machine shop tools.
• Deep knowledge of GD&T as well as proficiency with SolidWorks.
• Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks.

Preferred Qualifications:

• Master’s degree in Mechanical Engineering or equivalent.
• Knowledge/experience with plastic injection molding.
• Knowledge/experience with DOE, SPC, JMP /Minitab.
• Experience with metal stamping, laser cutting and chemical etching.
• Familiarity with and sterilization process and aseptic environment.
• PLC programming, SCADA, Ladder Logic preferred.