GENERAL INFORMATION
Position Title
Sr. Manufacturing Process Engineer
Department
Manufacturing
Reports To
Process Engineering Department
Purpose of the Job
The Sr. Manufacturing Process Engineer supports and leads advanced manufacturing activities for Rani Capsules. This role provides technical leadership in developing, revamping, and optimizing manufacturing processes and equipment. The engineer collaborates with R&D, Quality, and Operations teams to ensure product specifications conform to regulatory and business requirements, while driving innovation, efficiency, and compliance across production lines. The position also contributes to policy development and process standardization, ensuring alignment with strategic business objectives.
Major Duties And Responsibilities
- Lead the design, implementation, and continuous improvement of complex manufacturing processes, ensuring scalability, reliability, and cost-effectiveness.
- Revamp entire manufacturing workflows to enhance productivity, quality, and compliance while reducing cost and labor.
- Conduct advanced process capability studies and Design of Experiments (DOEs); utilize statistical analysis software (Minitab, JMP) to interpret results and propose actionable improvements.
- Develop new process policies, procedures, and standards that improve cross-departmental efficiency and regulatory robustness.
- Mentor and guide junior engineers by reviewing work, providing feedback, and delegating subprojects within larger manufacturing initiatives.
- Contributes to and influences strategic decisions impacting manufacturing and product delivery.
- Design and execute process validation protocols (IQ, OQ, PQ) at manufacturing scale; collaborate with Quality and Validation departments to meet business demands.
- Troubleshoot complex manufacturing issues through root cause analysis, coordinating with multidisciplinary teams to implement sustainable corrective actions.
- Drive cross-functional initiatives to ensure manufacturing processes align with R&D, Quality, and Supply Chain objectives.
- Analyze high-complexity data sets to monitor process performance, identify improvement areas, and optimize throughput and yield.
- Develop and maintain comprehensive manufacturing documentation, including MPIs, LHRs, and WIs, ensuring consistency and compliance with QMS standards.
- Represent Manufacturing Engineering in strategic discussions, providing technical recommendations that influence broader business and operational decisions.
- Promotes open exchange of ideas, feedback, and collaboration across departments and teams.
- Serves as a representative of the company, demonstrating accountability and acting in its best interest.
Qualifications
- Bachelor's Degree in Mechanical, Chemical, Manufacturing or related engineering fields
- 6-8 years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
- Excellent verbal, written, presentation and interpersonal skills
- Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.
- Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
- Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
- 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
- Knowledge of material science and polymer chemistry
- Diverse background in process characterization and optimization in a manufacturing environment.
- Hands-on proactive approach to problem solving
- Requires interaction and collaboration with a cross-functional team
Preferred Qualifications
- Experience with Statistical Software tools such as Minitab or JMP
- Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
- Familiarity with cleaning and sterilization processes
- Working knowledge of SolidWorks
