Senior Manufacturing Engineer I

Kindeva Drug Delivery • Brentwood, MO

1d • Onsite

About The Position

Our Work Matters
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: The Senior Manufacturing Engineer is responsible for the design, implementation, optimization, troubleshooting, and lifecycle management of aseptic manufacturing processes and equipment used in the production of sterile pharmaceutical and/or biopharmaceutical products. The role requires a strong focus on driving quality into production processes, implementation of best practices, and continuous improvement. This role plays a key technical role in maintaining sterility assurance, driving equipment reliability, supporting regulatory compliance (cGMP, EU Annex 1), and leading or significantly contributing to process improvements, automation enhancements, and validation activities in ISO 5/Grade A cleanroom environments.

Requirements

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Electrical Engineering, or a closely related technical discipline required.
• Minimum of 5 years of hands-on engineering experience in a cGMP-regulated pharmaceutical, biopharmaceutical, or sterile medical device manufacturing environment.
• Demonstrated experience supporting or leading aseptic processing, sterile fill-finish, or cleanroom operations.
• Proficiency in mechanical design software: SolidWorks, AutoCAD, Inventor, or equivalent (required: creation of complex 3D models, assemblies, detailed drawings, and tolerance analysis).
• Automation experience: PLC programming (ladder logic, structured text), HMI/SCADA development, troubleshooting industrial control systems, and integration of robotic arms, servo systems, and vision technologies.
• Knowledge of aseptic fill-finish equipment: peristaltic/rotary piston pumps, vial/syringe/cartridge fillers, stoppering/capping systems, isolators/RABS, VHP decontamination, and barrier technologies.
• Solid understanding of process control, instrumentation, sensors, actuators, and data acquisition systems.
• Knowledge of cGMP requirements, EU Annex 1 contamination control strategy, sterility assurance, and cleanroom classification.

Nice To Haves

• Experience executing or leading process/equipment validation, media fills, and cleaning validation in aseptic environments.
• Familiarity with data analytics tools (Excel, Minitab, JMP, OSIsoft PI) for process monitoring, capability analysis, and statistical evaluation.
• Exposure to lean manufacturing, Six Sigma, or reliability-centered maintenance methodologies.
• Previous involvement in capital project execution or technology transfer projects.
• Strong analytical and problem-solving skills with a systematic approach to complex technical issues.
• Excellent technical writing and documentation skills (protocols, reports, investigations).
• Proven ability to work independently and lead small cross-functional teams or projects.
• High attention to detail and commitment to contamination control and quality standards.
• Effective communicator capable of presenting technical information to diverse audiences.
• Willingness to gown and work in Grade A/B cleanroom environments.

Responsibilities

• Effectively manage and coordinate aseptic manufacturing technical processes and functions at the site in support of technical projects.
• Lead or independently execute the design, modification, optimization, and qualification of aseptic process equipment and systems, including filling lines, isolators, RABS, autoclaves, CIP/SIP skids, formulation vessels, and clean utilities.
• Develop and maintain detailed technical documentation, including P&IDs, equipment specifications, 3D models, mechanical assemblies, and detailed fabrication drawings using SolidWorks, AutoCAD, or equivalent CAD platforms.
• Troubleshoot and optimize automation systems including PLCs (Allen-Bradley, Siemens), HMIs, industrial networks, robotic material handling, vision inspection systems, and SCADA platforms used in aseptic filling and finishing.
• Perform in-depth root cause analysis (RCA) on mechanical, automation, and process deviations; author and implement CAPAs; and drive permanent corrective solutions to improve yield, reduce downtime, and strengthen contamination control.
• Own or lead equipment installation, commissioning, qualification (IQ/OQ/PQ), process validation, cleaning validation, and media fill simulations for new installations, upgrades, or technology transfers.
• Serve as technical SME for aseptic equipment and automation during regulatory inspections, audits, and risk assessments (FMEA, HAZOP).
• Lead or significantly contribute to change controls, process improvement projects, and capital projects aimed at enhancing sterility assurance, throughput, and operational efficiency.
• Collaborate closely with Quality Assurance, Validation, Production, Maintenance, and Automation teams to ensure processes remain in a validated state and meet global regulatory expectations (FDA, EMA, ISO 14644, USP /EU Annex 1).
• Author, review, and approve SOPs, batch records, preventive maintenance plans, calibration procedures, and engineering protocols/reports.
• Support cleanroom performance qualification activities, including airflow visualization (smoke studies), particle monitoring, pressure cascade management, and personnel/material flow optimization.
• Provide technical guidance and training to manufacturing and maintenance personnel on equipment operation, troubleshooting, and best practices.
• Participate in off-shift, weekend, or on-call support during critical manufacturing campaigns, validation runs, or major investigations as required.

Benefits

• Opportunity to take ownership of high-impact aseptic systems and automation projects.
• Exposure to state-of-the-art fill-finish and barrier technologies.
• Career development path toward Principal Engineer or technical leadership roles.
• Competitive salary, bonus eligibility, and comprehensive benefits package.
• Structured technical training and mentorship opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level