Senior Manufacturing Engineer

Kindeva Drug Delivery•Bridgeton, MO

146d•Onsite

About The Position

The Senior Manufacturing Engineer serves as a technical leader and subject matter expert responsible for the design, implementation, optimization, troubleshooting, and lifecycle management of aseptic manufacturing processes and equipment used to produce sterile pharmaceutical and/or biopharmaceutical products. The role provides strategic engineering support for reliable, compliant, high-performance aseptic manufacturing of injectable drug products, including vials, syringes, and cartridges. It drives process optimization, contamination control, equipment lifecycle management, and continuous improvement while maintaining compliance with cGMP, FDA, EMA, ISO, and other regulatory requirements. The engineer provides technical leadership for aseptic fill-finish operations, equipment and process lifecycle activities, validation, investigations, and manufacturing support. The role also collaborates across quality, validation, microbiology, regulatory, supply chain, operations, and MSAT; supports technology transfers, new product introductions, regulatory inspections, and capital projects; and mentors junior engineers and manufacturing personnel.

Requirements

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline.
At least 3 years of hands-on engineering experience in a cGMP-regulated pharmaceutical, biopharmaceutical, or sterile medical device manufacturing environment.
Experience with isolator technology, RABS, vial/syringe/cartridge filling lines, lyophilization, aseptic connections, and closed-system processing.
Proven track record supporting sterile product manufacturing.

Nice To Haves

Proficiency in SolidWorks, AutoCAD Inventor, or equivalent mechanical design software, including creation of complex 3D models, assemblies, detailed drawings, and tolerance analysis (listed as required in the posting).
Automation knowledge, including PLC programming in ladder logic or structured text, HMI/SCADA development, industrial control system troubleshooting, and integration of robotic arms, servo systems, and vision technologies.
In-depth knowledge of aseptic fill-finish equipment, including peristaltic and rotary piston pumps, vial/syringe/cartridge fillers, stoppering and capping systems, isolators/RABS, VHP decontamination, and barrier technologies.
Understanding of process control, instrumentation, sensors, actuators, and data acquisition systems.
Familiarity with Excel, Minitab, JMP, or OSIsoft PI for process monitoring, capability analysis, and statistical evaluation.
Knowledge of cGMP requirements, EU Annex 1 contamination control strategy, sterility assurance, and cleanroom classification.
Experience executing or leading process/equipment validation, media fills, and cleaning validation in aseptic environments.
Exposure to Lean manufacturing, Six Sigma, or reliability-centered maintenance methodologies.
Previous involvement in capital project execution or technology transfer projects.

Responsibilities

Serve as the primary subject matter expert for aseptic manufacturing equipment, utilities, and fill-finish systems.
Provide technical leadership for aseptic fill-finish process design, scale-up, validation, troubleshooting, and performance monitoring.
Implement and sustain aseptic practices and contamination control strategies across sterile operations.
Lead or support equipment and process lifecycle activities, including design reviews, FAT/SAT, IQ/OQ, requalification, and decommissioning.
Author, review, and approve technical documents, including SOPs, batch records, change controls, deviations, CAPAs, risk assessments, validation protocols and reports, investigation reports, preventive maintenance plans, calibration procedures, and engineering protocols and reports.
Perform root cause analysis of mechanical, automation, environmental, and process deviations, and implement CAPAs to improve yield, reduce downtime, and strengthen contamination control.
Drive process optimization and continuous improvement using Lean, Six Sigma, and data-driven approaches to increase yield, reduce cycle time and interventions, and enhance sterility assurance.
Provide engineering oversight and real-time shop-floor troubleshooting support during manufacturing campaigns.
Collaborate with Quality Assurance, Validation, Microbiology, Regulatory, Supply Chain, Operations, and MSAT on technology transfers, new product introductions, and regulatory inspections.
Support regulatory submissions and inspections by preparing technical packages and defending aseptic processes.
Lead or contribute to change controls, process improvement initiatives, and capital projects that improve sterility assurance, throughput, and operational efficiency.
Support cleanroom performance qualification, including airflow visualization, particle monitoring, pressure cascade management, and personnel and material flow optimization.
Mentor and provide technical guidance to junior engineers, manufacturing technicians, and cross-functional team members.
Monitor and analyze process performance metrics, including yield, intervention rate, environmental monitoring trends, and downtime, and implement improvements.